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3. Macro-modelling of the Three-Dimensional Interaction Between the Faces of a Steel Tubular Column Joint

Author

Miculaş, C. V., Costa, R. J., Simões da Silva, Luís, Simões, R., Craveiro, H., Tankova, T., di Prisco, Marco, Series Editor, Chen, Sheng-Hong, Series Editor, Vayas, Ioannis, Series Editor, Kumar Shukla, Sanjay, Series Editor, Sharma, Anuj, Series Editor, Kumar, Nagesh, Series Editor, Wang, Chien Ming, Series Editor, Di Trapani, Fabio, editor, Demartino, Cristoforo, editor, Marano, Giuseppe Carlo, editor, and Monti, Giorgio, editor

Published
2023
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4. A case of mody 2 - Associated hyperglycemia diagnosed as gestational diabetes

Author

Chakarova N., Balabanski L., Dimova R., Tsarkova P., and Tankova T.

Subjects
monogenic diabetes, mody 2, gestational diabetes, Genetics, QH426-470
Abstract

Maturity-onset diabetes of the young (MODY) is the most common monogenic form of diabetes, accounting for 1-2% of all diabetes cases. At least 14 different MODY subtypes have been identified the most common of which is MODY 2 caused by mutations in the glucokinase (GSK) gene. The mild hyperglycemia of MODY 2 is often first detected during pregnancy. Patients with MODY are usually misdiagnosed as either idiopathic type 1 or type 2 diabetes. The recognition of MODY 2 during pregnancy has important clinical implications as the management of hyperglycemia may differ from the established algorithm in gestational diabetes. Fetus development could be seriously affected in case it has inherited the GSK mutation and maternal hyperglycemia is insulin treated to the pregnancy adopted glycemic targets.

Published
2023
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7. Lateral-torsional buckling resistance of non-prismatic and prismatic mono-symmetric I-section steel beams based on stress utilization

Author

Gomes, J. O. (author), Simões da Silva, L. (author), Tankova, T. (author), Carvalho, H. (author), Filho, J. O. Ferreira (author), Gomes, J. O. (author), Simões da Silva, L. (author), Tankova, T. (author), Carvalho, H. (author), and Filho, J. O. Ferreira (author)

Abstract

The lateral-torsional resistance of prismatic double-symmetric I-section beams is accurately predicted using a mechanically consistent Ayrton-Perry approach, combined with a calibrated generalized imperfection. The corresponding design formulation was recently adopted in the revised version of Eurocode 3. However, for prismatic mono-symmetric I-section beams, the General Case shall be used while for non-prismatic beams only the General Method is available. Both methods present a very large scatter and highly underestimate the lateral-torsional buckling resistance. This paper proposes an extension to the General Formulation for non-prismatic beams with arbitrary boundary conditions, partial lateral restraints, and arbitrary loading for mono-symmetric I-sections. Using an advanced numerical model calibrated with experimental test results, a large parametric study is undertaken, and its results are used to assess the available design methodologies and the proposed method. It is concluded that the General Formulation provides excellent safe-sided estimates of the LTB resistance, and it is confirmed the very poor performance of the General Case and the General Method., Steel & Composite Structures

Published
2024
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8. Mechanical properties of 3D printed CMT-WAAM 316 LSi stainless steel walls

Author

Andrade, D. G. (author), Tankova, T. (author), Zhu, C. (author), Branco, R. (author), da Silva, L. Simões (author), Rodrigues, D. M. (author), Andrade, D. G. (author), Tankova, T. (author), Zhu, C. (author), Branco, R. (author), da Silva, L. Simões (author), and Rodrigues, D. M. (author)

Abstract

The use of 3D printed stainless steel requires a deep knowledge of its mechanical properties. This paper presents material characterisation of 316LSi austenitic stainless-steel coupons manufactured by CMT-WAAM, considering different deposition directions. The specimens were tested according to ISO 6892-1, the fractures surfaces were examined by SEM for machined and as-built conditions. The material was subject to hardness test and deep microstructural analyses, to assess the anisotropy in material properties at the micro and macro scales, respectively. A thermal analysis performed by infrared thermography of the material deposition in CMT-WAAM was also performed to establish the influence of the temperature evolution (versus time and position) on the microstructural and mechanical properties of the deposited walls. Finally, a statistical assessment was carried out, including results available in the literature and a material model available in the literature was adjusted to the test results, enabling to conclude that it is possible of accurately reproducing the uniaxial stress-strain behaviour, therefore providing a necessary input for the design of steel structures with 3D printed stainless steel., Steel & Composite Structures

Published
2024
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9. Influence of geometrical imperfections and residual stresses on the reliability of high strength steel welded I-section columns using Monte Carlo simulation

Author

Ferreira Filho, José Osvaldo (author), da Silva, Luís Simões (author), Tankova, T. (author), Carvalho, Hermes (author), Ferreira Filho, José Osvaldo (author), da Silva, Luís Simões (author), Tankova, T. (author), and Carvalho, Hermes (author)

Abstract

This paper aims to assess the influence of geometrical imperfections and residual stresses on the reliability of the stability design rules for steel columns in Eurocode 3 considering a full probabilistic approach and further validate the new buckling curves in the scope of the ongoing revision of the Structural Eurocodes. A reliability assessment of major- and minor-axis flexural buckling of high-strength steel (HSS) welded I-section columns was performed, considering all basic variables as random, including the geometrical and material imperfections, in addition to the material properties of steel and the geometry of the cross-section. An advanced finite element model calibrated with experimental test results is used to perform a very large (290,126 simulations) parametric study covering the majority of practical geometries. Subsequently, Monte Carlo simulation is used to estimate the design values of the buckling resistance that correspond to the target probability of failure of the Eurocodes. Finally, these values are compared to the proposed buckling curves for HSS columns, showing good agreement and supporting their adoption in the revised EN 1993–1-1. It is also concluded that it is on the safe side to carry out a reliability assessment with deterministic reference values for structural imperfections., Steel & Composite Structures

Published
2024
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10. 3D macro-element for innovative plug-and-play joints

Author

Miculaş, Cristian V. (author), Costa, Ricardo J. (author), da Silva, Luis Simões (author), Simões, Rui (author), Craveiro, Helder (author), Tankova, T. (author), Miculaş, Cristian V. (author), Costa, Ricardo J. (author), da Silva, Luis Simões (author), Simões, Rui (author), Craveiro, Helder (author), and Tankova, T. (author)

Abstract

This paper presents the development, implementation, and validation of a macro-element suitable for the linear analysis of innovative 3D plug-and-play joints between tubular columns and lightweight steel truss-girders. The macro-element is based on the component method, accounts for the three-dimensional interaction between the tube faces, and its components have a clear physical meaning. Simplified procedures are developed for the closed-form computation of the stiffness matrix of the macro-element based on the geometric and mechanical properties of the nodal zone. This facilitates practical application in everyday design scenarios. Furthermore, the macro-element's architecture is implemented in the framework of OpenSees as a standalone beam-to-column joint finite element. Validation of the conceptual design is accomplished through parametric studies, comparing its performance with models generated in higher-order finite element commercial software, Abaqus. This research offers a valuable resource for the linear analysis and design of innovative 3D plug-and-play joint connections in structural engineering, enhancing efficiency and reliability in construction practices., Steel & Composite Structures

Published
2024
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11. Assessment of cyclic deformation behaviour of wire arc additively manufactured carbon steel

Author

Mendez-Morales, Mariela (author), Branco, Ricardo (author), Tankova, T. (author), Rebelo, Carlos (author), Mendez-Morales, Mariela (author), Branco, Ricardo (author), Tankova, T. (author), and Rebelo, Carlos (author)

Abstract

Wire Arc Additive Manufacturing (WAAM) has gained popularity due to its speed and cost-effectiveness. However, the current knowledge on the cyclic deformation behaviour of WAAM materials is limited. To address this issue, this study investigates the cyclic deformation behaviour of WAAM ER70S-6 carbon steel. Coupons were extracted from printed walls with horizontal and vertical orientations and from surface and interior locations. Low-cycle fatigue tests were performed under fully reversed strain-controlled conditions, spanning strain amplitudes from 0.20 % to 1.50 %. Regardless of the group, the material exhibited cyclic hardening for strain amplitudes above 0.60 % and cyclic softening for smaller strain amplitudes. Significant non-Masing hysteretic behaviour was also observed. Cyclic stress–strain curves and fatigue-life relationships written in terms of stress, strain and energy-based parameters were derived for all groups. Fatigue life was not significantly influenced by printing orientation or location across thickness. However, horizontal orientation resulted in a slightly superior fatigue response. A statistical analysis revealed no significant difference in the accuracy of fatigue-life relationships between the groups. Finally, a comparative study between WAAM materials and conventional steels showed promising results. Yet, conventional steels outperform WAAM carbon steel, at least doubling the fatigue life for the same value of the damage parameter., Steel & Composite Structures

Published
2024
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14. Design of pin connections between steel members

Author

Conde, Jorge (author), da Silva, Luis S. (author), Tankova, T. (author), Simões, Rui (author), Abecasis, Tiago (author), Conde, Jorge (author), da Silva, Luis S. (author), Tankova, T. (author), Simões, Rui (author), and Abecasis, Tiago (author)

Abstract

The design of pin connections between steel members has been established for many years in design codes. However, recently, in the scope of the revision of Eurocode 3, Part 1–8 (EN 1993–1-8), questions were raised concerning the safety of the corresponding design verifications. This paper identifies two main aspects that require revision, namely: (i) the possibility to design a pin as a bolt in shear and (ii) the verification of the resistance of the pin itself. Based on a thorough literature review, experimental tests and a parametric study, a new proposal submitted to CEN as an amendment to the code, is presented to solve these two identified issues., Green Open Access added to TU Delft Institutional Repository 'You share, we take care!' - Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public., Steel & Composite Structures

Published
2023
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15. A model for the initial stiffness of the face plate component

Author

Conde, Jorge (author), Simões da Silva, Luis (author), Francisca Santos, Ana (author), Lemma, Melaku Seyoum (author), Tankova, T. (author), Conde, Jorge (author), Simões da Silva, Luis (author), Francisca Santos, Ana (author), Lemma, Melaku Seyoum (author), and Tankova, T. (author)

Abstract

The component method for joint analysis relies on the formulation of stiffness and strength of individual parts to derive the global properties of the joint. One of these components is the web of an open I-section, or the face of a rectangular hollow section, hereby referred to as face plate. It is currently not codified despite its frequent occurrence in the engineering practice. Hereby, a new mechanical model is proposed to estimate the initial stiffness of the face plate component under out-of-plane loading, leading to closed-form analytical expressions. The model is validated against experimental test results and an extensive numerical parametric study, showing excellent agreement., Steel & Composite Structures

Published
2023
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16. Epigenetic alterations in patients with type 2 diabetes mellitus

Author

Karachanak-Yankova S, Dimova R, Nikolova D, Nesheva D, Koprinarova M, Maslyankov S, Tafradjiska R, Gateva P, Velizarova M, Hammoudeh Z, Stoynev N, Toncheva D, Tankova T, and Dimova I

Subjects
dna methylation, epigenetic changes, methyl-cpg-binding domain protein 2 (mbd2), stress and toxicity genes, tumorigenesis, type 2 diabetes mellitus (t2dm), Genetics, QH426-470
Abstract

Epigenetic changes, in particular DNA methylation processes, play a role in the pathogenesis and progression of type 2 diabetes mellitus (T2DM) linking genetic and environmental factors. To clarify this role, we have analyzed in patients with different duration of T2DM: (i) expression levels of methyl-CpG-binding domain protein 2 (MBD2) as marker of DNA methylation, and ii) methylation changes in 22 genes connected to cellular stress and toxicity. We have analyzed MBD2 mRNA expression levels in16 patients and 12 controls and the methylation status of stress and toxicity genes in four DNA pools: (i) controls; (ii) newly-diagnosed T2DM patients; (iii) patients with T2DM duration of 5 years. The MBD2 expression levels were 10.4-times increased on average in T2DM patients compared to controls. Consistent increase in DNA methylation fraction with the increase in T2DM duration was observed in Prdx2 and SCARA3 genes, connected to oxidative stress protection and in BRCA1 and Tp53 tumor-suppressor genes. In conclusion, increased MBD2 expression in patients indicated general dysregulation of DNA methylation in T2DM. The elevated methylation of Prdx2 and SCARA3 genes suggests disturbance in oxidative stress protection in T2DM. The increased methylation of BRCA1 and Tp53 genes unraveled an epigenetic cause for T2DM related increase in cancer risk.

Published
2015
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18. Efficacy and Safety of Once-Weekly Semaglutide 2.0 mg vs. 1.0 mg by Baseline HbA1c and BMI: SUSTAIN FORTE Subgroup Analyses

Author

Buse, John B., additional, Auerbach, Pernille, additional, Bajaj, Harpreet S., additional, Fukushima, Yasushi, additional, Lingvay, Ildiko, additional, Macura, Stanislava, additional, Gollan, Rene, additional, Søndergaard, Anette L., additional, Tankova, T svetalina, additional, Tentolouris, Nikolaos Tentolouris Nikolaos, additional, and Frias, Juan P., additional

Published
2022
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19. Expert Panel Guidance and Narrative Review of Treatment Simplification of Complex Insulin Regimens to Improve Outcomes in Type 2 Diabetes

Author

Jude, EB, Malecki, MT, Gomez Huelgas, R, Prazny, M, Snoek, F, Tankova, T, Giugliano, D, Khunti, K, Jude, EB, Malecki, MT, Gomez Huelgas, R, Prazny, M, Snoek, F, Tankova, T, Giugliano, D, and Khunti, K

Abstract

Given the progressive nature of type 2 diabetes (T2D), most individuals with the disease will ultimately undergo treatment intensification. This usually involves the stepwise addition of a new glucose-lowering agent or switching to a more complex insulin regimen. However, complex treatment regimens can result in an increased risk of hypoglycaemia and high treatment burden, which may impact negatively on both therapeutic adherence and overall quality of life. Individuals with good glycaemic control may also be overtreated with unnecessarily complex regimens. Treatment simplification aims to reduce individual treatment burden, without compromising therapeutic effectiveness or safety. Despite data showing that simplifying therapy can achieve good glycaemic control without negatively impacting on treatment efficacy or safety, it is not always implemented in clinical practice. Current clinical guidelines focus on treatment intensification, rather than simplification. Where simplification is recommended, clear guidance is lacking and mostly focused on treatment of the elderly. An expert, multidisciplinary panel evaluated the current treatment landscape with respect to guidance, published evidence, recommendations and approaches regarding simplification of complex insulin regimens. This article outlines the benefits of treatment simplification and provides practical recommendations on simplifying complex insulin treatment strategies in people with T2D using illustrative cases.

Published
2022

20. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Author

Davies, M. J., Aroda, V. R., Collins, B. S., Gabbay, R. A., Green, J., Maruthur, N. M., Rosas, S. E., Del Prato, S., Mathieu, C., Mingrone, Geltrude, Rossing, P., Tankova, T., Tsapas, A., Buse, J. B., Mingrone G. (ORCID:0000-0003-2021-528X), Davies, M. J., Aroda, V. R., Collins, B. S., Gabbay, R. A., Green, J., Maruthur, N. M., Rosas, S. E., Del Prato, S., Mathieu, C., Mingrone, Geltrude, Rossing, P., Tankova, T., Tsapas, A., Buse, J. B., and Mingrone G. (ORCID:0000-0003-2021-528X)

Abstract

The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the previous consensus statements on the management of hyperglycaemia in type 2 diabetes in adults, published since 2006 and last updated in 2019. The target audience is the full spectrum of the professional healthcare team providing diabetes care in the USA and Europe. A systematic examination of publications since 2018 informed new recommendations. These include additional focus on social determinants of health, the healthcare system and physical activity behaviours including sleep. There is a greater emphasis on weight management as part of the holistic approach to diabetes management. The results of cardiovascular and kidney outcomes trials involving sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists, including assessment of subgroups, inform broader recommendations for cardiorenal protection in people with diabetes at high risk of cardiorenal disease. After a summary listing of consensus recommendations, practical tips for implementation are provided.

Published
2022

21. Effects of state-of-the-art residual stress models on the member and local stability behaviour

Author

Schaper, Lukas (author), Tankova, T. (author), da Silva, Luís Simões (author), Knobloch, Markus (author), Schaper, Lukas (author), Tankova, T. (author), da Silva, Luís Simões (author), and Knobloch, Markus (author)

Abstract

Residual stresses have considerable effect on both the local and the member stability behaviour of steel structures. Previous studies have shown that the structural stability behaviour depends on both the distribution and the amplitude of the residual stresses. The residual stress distribution is affected by the cross-section geometry, the steel grade and the manufacturing process, e.g. flame cutting and the welding procedure. A realistic consideration of residual stresses is necessary for an efficient and safe design of steel structures. This article presents an experimental and numerical study on the influence of residual stresses on the stability behaviour of structural members, i.e. steel columns and beams considering a variety of cross-sectional slenderness, i.e. plastic, compact and slender cross-sections are taken into account. A novel residual stress model for welded I-shaped sections was developed and evaluated using test data. This model takes into account the main influencing parameters, i.e. the cross-sections geometry, the steel grade as well as manufacturing process with thermal cuts or non-thermal cuts of the steel plates. The novel residual stress model is then used to investigate the stability behaviour in terms of a numerical simulation study. The result of the study allows to propose an improvement of the buckling curve selection for welded high strength steel columns and beams., Steel & Composite Structures

Published
2022
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22. Characterization of robotized CMT-WAAM carbon steel

Author

Tankova, T. (author), Andrade, David (author), Branco, Ricardo (author), Zhu, Carlos (author), Rodrigues, Dulce (author), Simões da Silva, Luís (author), Tankova, T. (author), Andrade, David (author), Branco, Ricardo (author), Zhu, Carlos (author), Rodrigues, Dulce (author), and Simões da Silva, Luís (author)

Abstract

This paper analyses the microstructural and mechanical properties of carbon steel coupons produced by CMT-WAAM. The strategy adopted in the fabrication of the test specimens using a robotised facility is explained. Then, the results of the mechanical characterization performed using as-built and machined samples, extracted in several directions (0°, 45°, 90°) relative to the material deposition trajectory, are analysed. The yield and ultimate tensile strengths were determined by performing tensile tests and the Young's modulus was determined using ultra-micro hardness measurements. A deep microstructural characterization was also performed by optical microscopy for establishing a direct relationship between the manufacturing procedures and the registered mechanical properties. The failure micro-mechanisms associated with the building orientation and the surface condition was also examined by scanning electron microscopy. It was found out that the additive manufactured material has isotropic tensile properties, which result from the formation of an annealed microstructure upon cooling from the successive CMT-WAAM thermal cycles. The machined specimens exhibit higher strength and ductility than the as-built ones. The fracture surfaces of both machined and as-built coupons showed ductile failure. The results of the uniaxial tensile tests indicate that the machined and as-built WAAM steel walls satisfy the requirements of a structural steel grade as specified by Eurocode 3., Steel & Composite Structures

Published
2022
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25. Association between daily number of eating occasions with fasting glucose and insulin sensitivity in adults from families at high risk for type 2 diabetes in Europe: the Feel4Diabetes Study

Author

Apergi, K. Karatzi, K. Reppas, K. Mavrogianni, C. Shadid, S. P, F.-B. De Miguel-Etayo, P. Bazdarska, Y. Radó, S. Rurik, I. Wikström, K. Tankova, T. Gardon, G. Iotova, V. Manios, Y. Makrilakis, K.

Abstract

Objective: The aim of this study was to examine the association between the number of times one eats daily (termed eating occasions [EO]) with indices of glycemic control and insulin resistance (IR) in a large sample of adults from families at high risk for type 2 diabetes mellitus (T2DM) from six European countries. The study also considered sex and socioeconomic status (SES). Methods: Standardized questionnaires and procedures were used to assess sociodemographic characteristics, dietary intake, sedentary behavior, and anthropometric and biochemical indices. Univariate analysis of variance was used to investigate associations of daily EOs with fasting glucose (FG), fasting insulin (FI), and IR. Results: In 1552 adults (41.6 ± 7.2 y), three to four daily EOs rather than less than three were inversely associated with FG (β = –2.598; 95% confidence interval [CI], –4.521 to –0.675), independent of age, body mass index (BMI), dietary quality, and sedentary time. In women, three to four EOs per day were also associated with FG (β = –3.071; 95% CI to –5.573 to –0.570) independently of the mentioned confounders. In high SES participants, having more than four EOs per day had an inverse association with FI (β = –1.348; 95% CI to –2.583 to –0.114). No such associations were observed in men or in low SES participants. Conclusion: In adults at high risk for T2DM, and especially in women, having three to four daily EOs was inversely associated with FG, whereas in high SES participants, more than four EOs was associated with FI. Future studies should further elucidate the underlying mechanisms and offer insight into the optimum number of daily EOs for the prevention of T2DM especially in men and in adults with low SES where the number of daily EOs was not found to be significantly related to glycemic indices. © 2021 Elsevier Inc.

Published
2022

26. Sociodemographic, anthropometric, and lifestyle correlates of prediabetes and type 2 diabetes in europe: The Feel4Diabetes study

Author

Kontochristopoulou, A.M. Karatzi, K. Karaglani, E. Cardon, G. Kivelä, J. Wikström, K. Iotova, V. Tsochev, K. Tankova, T. Rurik, I. Radone, A.S. Liatis, S. Makrilakis, K. Moreno, L.A. Manios, Y.

Abstract

Background and aims: The current work aimed to identify the predominant correlates of prediabetes and T2DM among a variety of socio-demographic, anthropometric and lifestyle indices, in a large sample of adults from families at high risk for T2DM. Methods and results: In this cross-sectional study, 2816 adults were recruited from low-socioeconomic areas in high-income countries (HICs) (Belgium-Finland), HICs under austerity measures (Greece-Spain), and low/middle-income countries (LMICs) (Bulgaria-Hungary). A positive association between the male sex (OR, 95% C.I.2.77 (1.69–4.54)) and prediabetes was revealed compared to females, while there was a negative association between younger age (

Published
2022

27. Parental insulin resistance is associated with unhealthy lifestyle behaviours independently of body mass index in children: The Feel4Diabetes study

Author

González-Gil, E.M. Giménez-Legarre, N. Cardon, G. Mavrogianni, C. Kivelä, J. Iotova, V. Tankova, T. Imre, R. Liatis, S. Makrilakis, K. Schwarz, P. Timpel, P. Dupont, E. Couck, P. Manios, Y. Moreno, L.A.

Abstract

Parental health is associated with children’s health and lifestyles. Thus, the aim of the present study was to assess lifestyle behaviours of children of parents with insulin resistance (IR) and at risk of type 2 diabetes. 2117 European families from the Feel4Diabetes-study were identified as being at risk for diabetes with the FINDRISC questionnaire and included in the present study. One parent and one child per family were included. Parental IR was considered when homeostasis model assessment (HOMA) was equal or higher than 2.5. Children’s screen-time, physical activity and diet were assessed and clustered by K-means. Weight and height were measured and children’s body mass index (BMI) was calculated. For children, a Healthy Diet Score (HDS) was calculated. Linear regression and multilevel logistic regression analyses were performed to assess the associations between parental IR and children’s lifestyle behaviours in 2021. Children of parents with IR had higher BMI (p < 0.001) and spent more screen time (p = 0.014) than those of non-IR parents. Children of parents with IR had a lower value in the breakfast and vegetable components of the HDS (p = 0.008 and p = 0.05). Four lifestyle clusters were found. Children of IR parents had higher odds of being in a non-healthy cluster (OR: 1.19; 95%CI: 1.001–1.437). Conclusion: Having an IR parent was associated with a high screen time and an increased probability of having an unhealthy lifestyle pattern in children. These data point out that children’s lifestyles should be assessed in families with IR parents to provide tailored interventions.What is Known:• Children with diabetic or insulin-resistant parents could also develop this condition.• Unhealthy lifestyles are directly related with insulin resistance even in children.What is New:• Children from parents with insulin resistance have higher chances of unhealthy lifestyles.• A higher BMI was found for those children with an insulin-resistant parent. © 2022, The Author(s).

Published
2022

28. Dapagliflozin and cardiovascular outcomes in type 2 diabetes

Author

Wiviott, S, Raz, I, Bonaca, M, Mosenzon, O, Kato, E, Cahn, A, Silverman, M, Zelniker, T, Kuder, J, Murphy, S, Bhatt, D, Leiter, L, Mcguire, D, Wilding, J, Ruff, C, Nilsson, G, Fredriksson, M, Johansson, P, Langkilde, A, Sabatine, M, Bansilal, S, Furtado, R, Fish, M, Gabovitch, D, Jevne, A, Ahern, S, Im, K, Goodrich, E, Lowe, C, Fisher, N, Gannon, J, Trindade, S, Towarowski, A, Fox, Y, Johnsson, E, Ranft, S, Faber, B, Wallander, M, Weiss, A, Buskila, A, Abola, M, Ardissino, D, Averkov, O, Aylward, P, Bode, C, Bonnici, F, Bonora, E, Budaj, A, Cernea, S, Chiang, C, Cooper, M, Dalby, A, Deerochanawong, C, Dellborg, M, Diaz, R, Dimulescu, D, Eliaschewitz, F, Goudev, A, Hadjadj, S, Herrera, M, Huo, Y, Jermendy, G, Ji, L, Kadowaki, T, Kiss, R, Kooy, A, Kumar, K, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Merlini, P, Nauck, M, Nguyen, T, Nicolau, J, Ostgren, C, Ophuis, T, Padilla, F, Pais, P, Park, K, Parkhomenko, A, Ray, K, Rosenstock, J, Ruda, M, Satman, I, Shestakova, M, Smahelova, A, Spinar, J, Strojek, K, Sy, R, Tankova, T, Theroux, P, Tkac, I, Van Gaal, L, Wainstein, J, Harrington, R, Droller, M, Lee, K, Nesto, R, Tuomilehto, J, Hedlin, H, Desai, M, Sayfer, I, Alexanian, S, Awtry, E, Bentley-Lewis, R, Berger, C, Croce, K, Desai, A, Garg, R, Gelfand, E, Gignac, G, Goessling, W, Ho, C, Hochberg, E, Lane, A, Larrey, D, Leeman, D, Lewis, J, Link, M, Mcdonnell, M, Norden, A, Pande, A, Rosenberg, C, Rost, N, Ruberg, F, Schiff, E, Silverman, S, Singhal, A, Wagner, A, Wolpin, B, Aizenberg, D, Fernandez, M, Sala, J, Maffei, L, Luquez, C, Waitman, J, Rista, L, Nardone, L, Sposetti, G, Cantero, M, Alvarisqueta, A, Montana, O, Cuadrado, J, Cartasegna, L, Baccaro, C, Chertkoff, A, Sanabria, H, Vainstein, N, Amerena, J, Arya, K, D'Emden, M, Proietto, J, Moses, R, Colquhoun, D, Stranks, S, Lehman, R, Hamilton, A, Whelan, A, Simpson, R, Purnell, P, Abhayaratna, W, Hammett, C, Mckeirnan, M, Sullivan, D, Bach, L, Hughes, K, Mathieu, C, Vercammen, C, Scheen, A, Duyck, F, Cools, F, De Wolf, L, Verhaegen, A, Nobels, F, Missault, L, Crenier, L, Thoeng, J, Wollaert, B, Vandenbroucke, M, Borges, J, Turatti, L, Lima, F, dos Santos, F, Kerr Saraiva, J, Pereira, M, Pereira, A, Precoma, D, Filho, G, Reis, G, Maia, L, Bacheva, T, Temelkova-Kurktschiev, T, Maneva, S, Stoyanovska, B, Boshnyashka, R, Stoykova, Y, Georgiev, D, Tagarev, Z, Dimitrova, E, Vitkina, M, Yordanova, L, Temelkova, M, Vasileva, S, Kuneva, T, Zyumbyuleva, M, Daskalova, I, Genadieva, V, Boyanov, L, Farah, G, Lazarova, G, Georgieva, M, Krasteva, S, Slavcheva, A, Yabroudi, N, Veleva, N, Zlateva, A, Damyanova, V, Elenkova, A, Kotselova, T, Genov, K, Lyubenova, L, Temelkova, N, Harizanova, B, Zaharieva, S, Bajaj, H, Goldenberg, R, Aronson, R, Twum-Barima, D, Dumas, R, Kouz, S, Kaiser, S, Ajala, B, Cha, J, Teitelbaum, I, Chouinard, G, Woo, V, Dan Dattani, I, Mazza, G, Gaudet, D, Poirier, P, Conway, J, Dion, D, Mckeough, M, Manyari, D, Harris, S, St-Pierre, B, Yale, J, Landry, D, Gupta, M, Hramiak, I, Lau, D, 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E., Vorokhobina N., Ivanov I., Dudinskaya E., Konstantinov V., Kanderkova D., Pavlik L., Raslova K., Paulovic V., Babikova J., Belesova K., Merciakova M., Truban J., Vargova A., Fabryova L., Slovenska M., Plasil R., Tomasova L., Kollarova D., Spodniakova D., Kosikova M., Dzuponova J., Kurcova I., Skripova D., Gabrisova A., Kalinova S., Ranjith N., Burgess L., Mitha I., Conradie M., Distiller L., Pillai P., Pillay S., Horak A., Nethononda R., van den Berg E., Nortje H., Bayat J., Corbett C., Abelson M., van Zyl L., Pillay T., Wing J., Kapp C., Hidalgo Urbano R., Gonzalez Juanatey J., Blanco Coronado J., Bruguera Cortada J., Ferreiro Gutierrez J., Quesada Simon M., Castro A., Delgado Alvarez E., Freixa R., Boada A., Larnefeldt H., Mooe T., Koskinen P., Lagerback P., Linderfalk C., Liu B., Berndtsson Blom K., Tengmark B., Lindholm C., Ostgren C., Oweling M., Albertsson P., Alvarsson M., Fant S., Berglund O., Hsia C., Chiang C., Fang C., Ueng K., Wang K., Lai W., Mamanasiri S., Wongvipaporn C., Kuanprasert S., Thongsri T., Srimahachota S., Boonyavarakul A., Suwanwalaikorn S., Tantiwong P., Sritara P., Sriwijitkamol A., Sanguanwong S., Chotinaiwattarakul C., Piyayotai D., Balci M., Orbay E., Saygili F., Oguz A., Altuntas Y., Comlekci A., Karpenko O., Tkach S., Vlasenko M., Fushtey I., Pertseva T., Reshotko D., Mostovoy Y., Vizir V., Kraiz I., Amosova K., Batushkin V., Tseluyko V., Koval O., Strang C., Bodalia B., Pieters R., Turner W., Asamoah-Owusu N., White C., Calvert J., McNally D., Jones N., McKaig G., Thompson J., Mohr S., Simpson H., Conn P., McCoye A., Rivero O., Yazdani S., Ince C., Zeitlin J., Wharton T., Platt G., Anderson R. J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. 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D., Raz I., Bonaca M. P., Mosenzon O., Kato E. T., Cahn A., Silverman M. G., Zelniker T. A., Kuder J. F., Murphy S. A., Bhatt D. L., Leiter L. A., McGuire D. K., Wilding J. P. H., Ruff C. T., Nilsson G. I., Fredriksson M., Johansson P. A., Langkilde A. M., Sabatine M. S., Bansilal S., Furtado R., Fish M. P., Gabovitch D., Jevne A., Ahern S., Im K., Goodrich E. L., Lowe C., Fisher N., Gannon J., Trindade S., Towarowski A., Fox Y., Johnsson E., Ranft S., Faber B., Wallander M., Weiss A., Buskila A., Abola M. T. B., Ardissino D., Averkov O., Aylward P., Bode C., Bonnici F., Bonora E., Budaj A. J., Cernea S., Chiang C. E., Cooper M., Dalby A., Deerochanawong C., Dellborg M., Diaz R., Dimulescu D., Eliaschewitz F. G., Goudev A. R., Hadjadj S., Herrera M., Huo Y., Jermendy G., Ji L., Kadowaki T., Kiss R., Kooy A., Kumar K. M. P., Lewis B., Litwak L., Lopez-Sendon J., Ma R., Merlini P. A., Nauck M. A., Nguyen T. K., Nicolau J. C., Ostgren C. J., Ophuis T. O., Padilla F., Pais P., Park K. 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J., Muirhead N., Zimmermann R., Galiwango P., Tobe S., Priestman B., Zinman B., Ma J., Zhao X., Wang C., Zhang A., Dong Y., Dong X., Luo M., Guo J., Zheng Z., Li Y., Liang Y., Peng D., Maderic D., Spinarova L., Raclavska L., Ludka O., Rihacek I., Karasova J., Pelikanova M., Vlasakova H., Urbancova K., Zamrazil V., Hradec J., Vlasicova H., Racicka E., Okenka L., Naplava R., Skopecek J., Palova S., Krystl T., Pistek Z., Oznerova M., Andresova A., Sarbochova R., Taborska P., Petrova I., Stanek L., Reichert P., Lorenc Z., Szabo M., Petit C., Krempf M., Boye A., Dubois S., Clavel S., Gourdy P., Elbaz M., Jazayeri S., Gouet D., Verges B., Couffinhal T., Sendeski M., Klausmann G., Appel K., Pein M., Thieme R., Schumm-Draeger P., Jacob S., Toursarkissian N., Kleinecke-Pohl U., Tschope D., Ott P., Haak T., Nauck M., Derwahl K., Bugger H., Hui G., Tsang C., Zilahi Z., Puski L., Vangel S., Fulop T., Pall K., Hidvegi T., Revesz K., Koranyi L., Kajetan M., Kerenyi Z., Penzes J., Herczeg B., Laszloczky A., Turi T., Rapi J., Pentek Z., Gaal Z., Winkler G., Percs E., Czigany A., Harcsa E., Gurzo M., Tassaly J., Horthy R., Petro G., Farago K., Muller G., Varju I., Kirschner R., Kiss I., Bakai J., Kancz S., Marton Z., Kodur R., Yajnik C., Thomas N., Ayyar V., Iyengar P., Bashkin A., Daoud D., Itzhak B., Katz A., Tsur A., Nikolsky E., Atar S., Grossman A., Klainman E., Tsalihin D., Shotan A., Turgeman Y., Ferrario M., Merlini P., Piatti P., Zenari L., Trevisan R., Bosco B., Di Lorenzo L., Mannucci E., Avogaro A., Reimers B., Trimarco B., Silvestri O., Salvioni A., Nakagawa H., Sueyoshi A., Fukuda K., Yasumoto H., Matsubayashi S., Kawajiri K., Togashi Y., Senokuchi T., Ohta Y., Yamauchi T., Node K., Alcocer Gamba M., Herrera Marmolejo M., De los Rios Ibarra M., Gonzalez Galvez G., Garcia Cantu E., Leguizamo Dimas A., Luna Ceballos R., Medina Pech C., Stobschinski de Alba C., Gonzalez Gonzalez J., Padilla Padilla F., Fanghanel Salmon G., Robles Torres F., Lopez Rosas E., Pelayo Orozco E., Banda Elizondo R., Escalona Caamano A., Frenk Baron P., Aguilar Salinas C., Mustieles Rocha C., Vidrio Velazquez M., Rodriguez Briones I., Saldate Alonso M., Velasco Sanchez R., Groenemeijer B., Ronner E., Kuijper A., Strikwerda S., Van Kempen W., Gijsbers S., Oude Ophuis A., Swart H., Hoogenberg K., Hovens M., van Hessen M., Westerink J., Kragten J., Nierop P., Bax W., Hartong S., Nieuwdorp M., Gonkel F., Al Windy N., Troquay R., Schaafsma H., Lieverse A., Knufman N., Tirador L., Guenon M., Ferrolino A., Atilano A., Aportadera M., Que M., Denopol M., Tolentino M., Jimeno C., Wee J., Mirasol R., Panelo A., Roxas D., Abola M., Palmes P., Silva A., Salvador D., Rosita R., Maravilla L., Rogelio G., Pacheco E., Tin Hay L., Prado J., Krzyzagorska E., Witek R., Miklaszewicz B., Sudnik W., Pomiecko W., Bochenek A., Fares I., Wujkowski M., Korol M., Powierza S., Goch A., Miekus P., Siegel A., Skierkowska J., Romanczuk P., Cygler J., Landa K., Szyprowska E., Stachlewski P., Czerski T., Pawlowicz L., Sowinski D., Romanowski L., Rudzki H., Skorski M., Jasiel-Wojculewicz H., Stasiewski A., Budaj A., Kania G., Mirek-Bryniarska E., Wojnowski L., Korzeniak R., Oh T., Park K., Lee M., Lee K., Jang H., Kim S., Ku B., Cha B., Son H., Lee I., Park J., Yu S., Shon H., Rhee E., Cho J., Park T., Nam J., Pintilei E., Popescu A., Nafornita V., Gutu O., Dumitrescu A., Bala C., Caceaune E., Mindrescu N., Morosanu M., Bradescu O., Munteanu M., Voitec M., Vlaiculescu M., Hancu N., Diaconu Sotropa M., Lupu S., Mateescu A., Carlan L., Marton R., Lupusoru D., Mot A., Coman A., Zaharie D., Rebrov A., Shutemova E., Bolieva L., Khalimov Y., Statsenko M., Galyavich A., Koziolova N., Shapovalova Y., Pavlysh E., Strongin L., Vertkin A., Vishneva E., Pavlova M., Khasanov N., Antsiferov M., Gavrisheva I., Sokolova N., Vorobyev S., Morugova T., Sinitsina I., Ezhov A., Kobalava Z., Belenkiy D., Supryadkina T., Kazakov Y., Oschepkova E., Dreval A., Novikova T., Vishnevsky A., Chizhov D., Akatova E., Vorokhobina N., Ivanov I., Dudinskaya E., Konstantinov V., Kanderkova D., Pavlik L., Raslova K., Paulovic V., Babikova J., Belesova K., Merciakova M., Truban J., Vargova A., Fabryova L., Slovenska M., Plasil R., Tomasova L., Kollarova D., Spodniakova D., Kosikova M., Dzuponova J., Kurcova I., Skripova D., Gabrisova A., Kalinova S., Ranjith N., Burgess L., Mitha I., Conradie M., Distiller L., Pillai P., Pillay S., Horak A., Nethononda R., van den Berg E., Nortje H., Bayat J., Corbett C., Abelson M., van Zyl L., Pillay T., Wing J., Kapp C., Hidalgo Urbano R., Gonzalez Juanatey J., Blanco Coronado J., Bruguera Cortada J., Ferreiro Gutierrez J., Quesada Simon M., Castro A., Delgado Alvarez E., Freixa R., Boada A., Larnefeldt H., Mooe T., Koskinen P., Lagerback P., Linderfalk C., Liu B., Berndtsson Blom K., Tengmark B., Lindholm C., Ostgren C., Oweling M., Albertsson P., Alvarsson M., Fant S., Berglund O., Hsia C., Chiang C., Fang C., Ueng K., Wang K., Lai W., Mamanasiri S., Wongvipaporn C., Kuanprasert S., Thongsri T., Srimahachota S., Boonyavarakul A., Suwanwalaikorn S., Tantiwong P., Sritara P., Sriwijitkamol A., Sanguanwong S., Chotinaiwattarakul C., Piyayotai D., Balci M., Orbay E., Saygili F., Oguz A., Altuntas Y., Comlekci A., Karpenko O., Tkach S., Vlasenko M., Fushtey I., Pertseva T., Reshotko D., Mostovoy Y., Vizir V., Kraiz I., Amosova K., Batushkin V., Tseluyko V., Koval O., Strang C., Bodalia B., Pieters R., Turner W., Asamoah-Owusu N., White C., Calvert J., McNally D., Jones N., McKaig G., Thompson J., Mohr S., Simpson H., Conn P., McCoye A., Rivero O., Yazdani S., Ince C., Zeitlin J., Wharton T., Platt G., Anderson R. J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. B., Tran Q. K., Tran N., Nguyen D., and Nguyen V.

Abstract

BACKGROUND The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to ≥60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], ≥1.3; P≥0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P = 0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P = 0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87)

Published
2019

29. Effectiveness of a family-, school- And community-based intervention on physical activity and its correlates in Belgian families with an increased risk for type 2 diabetes mellitus- And Feel4Diabetes-study

Author

Huys, N. Van Stappen, V. Shadid, S. De Craemer, M. Androutsos, O. Wikström, K. Makrilakis, K. Moreno, L.A. Iotova, V. Tankova, T. Nánási, A. Manios, Y. Cardon, G. Manios, Y. Kontogianni, M. Androutsos, O. Moschonis, G. Tsoutsoulopoulou, K. Mavrogianni, C. Katsarou, C. Karaglani, E. Efstathopoulou, E. Kechribari, I. Maragkopoulou, K. Argyri, E. Douligeris, A. Nikolaou, M. Vampouli, E.-A. Kouroupaki, K. Koutsi, R. Tzormpatzaki, E. Manou, E. Mpinou, P. Karachaliou, A. Filippou, C. Filippou, A. Lindström, J. Laatikainen, T. Wikström, K. Nelimarkka, K. Kivelä, J. Valve, P. Cardon, G. Latomme, J. Van Stappen, V. Huys, N. Annemans, L. Pil, L. Schwarz, P. Panchyrz, I. Holland, M. Timpel, P. Makrilakis, K. Liatis, S. Dafoulas, G. Lambrinou, C.-P. Giannopoulou, A. Tsirigoti, L. Fappa, E. Anastasiou, C. Zachari, K. Rabemananjara, L. Kakoulis, D. Mandalia, M. De Sabata, M.S. Pall, N. Civeira, F. Bueno, G. De Miguel-Etayo, P. Gonzalez-Gil, E.M. Mesana, M.I. Vicente-Rodriguez, G. Rodriguez, G. Baila-Rueda, L. Cenarro, A. Jarauta, E. Mateo-Gallego, R. Iotova, V. Tankova, T. Usheva, N. Tsochev, K. Chakarova, N. Galcheva, S. Dimova, R. Bocheva, Y. Radkova, Z. Marinova, V. Rurik, I. Ungvari, T. Jancsó, Z. Nánási, A. Kolozsvári, L. Martinez, R. Tong, M. Joutsenniemi, K. Wendel-Mitoraj, K.

Abstract

Background: The study aimed to investigate the effectiveness of the European Feel4Diabetes intervention, promoting a healthy lifestyle, on physical activity and its correlates among families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium. Methods: The Feel4Diabetes intervention involved three components: family, school and community component, with the family component consisting of 6 counseling sessions for families at risk. Main outcomes were objectively measured physical activity levels and its subjectively measured correlates. The final sample consisted of 454 parents (mean age 39.4 years; 72.0% women) and 444 children (mean age 8.0 years; 50.1% girls). Multilevel repeated measures analyses were performed to assess intervention effectiveness after 1 year. Results: In parents, there was no significant intervention effect. In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; ηp2 = 0.008) and steps (p = 0.03; ηp2 = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group. Conclusions: The F4D-intervention lacks effectiveness on high-risk families' physical activity and its correlates in Belgium. This could partially be explained by low attendance rates and a large drop-out. To reach vulnerable populations, future interventions should invest in more appropriate recruitment (e.g. more face-to-face contact) and more bottom-up development of the intervention (i.e. co-creation of the intervention with the target group). Trial registration: The Feel4Diabetes-study was prospectively registered at clinicaltrials.gov as NCT02393872 on 20 March 2015. © 2020 The Author(s).

Published
2020

31. Step Count Associations between Adults at Risk of Developing Diabetes and Their Children: The Feel4Diabetes Study

Author

Flores-Barrantes, P. Cardon, G. Iglesia, I. Moreno, L.A. Androutsos, O. Manios, Y. Kivelä, J. Lindström, J. De Craemer, M. Schwarz, P. Makrilakis, K. Annemans, L. Ko, W. Karatzi, K. Moschonis, G. Kanellakis, S. Mavrogianni, C. Tsoutsoulopoulou, K. Katsarou, C. Karaglani, E. Qira, I. Skoufas, E. Maragkopoulou, K. Tsiafitsa, A. Sotiropoulou, I. Tsolakos, M. Argyri, E. Nikolaou, M. Vampouli, E.-A. Filippou, C. Apergi, K. Filippou, A. Katerina, G. Dimitriadis, E. Laatikainen, T. Wikström, K. Valve, P. Levälahti, E. Virtanen, E. Pennanen, T. Olli, S. Nelimarkka, K. Van Stappen, V. Huys, N. Willems, R. Shadid, S. Timpel, P. Liatis, S. Dafoulas, G. Lambrinou, C.-P. Giannopoulou, A. Karuranga, E. Civeira, F. Bueno, G. De Miguel-Etayo, P. González-Gil, E.M. Miguel-Berges, M.L. Giménez-Legarre, N. Ayala-Marín, A.M. Seral-Cortés, M. Baila-Rueda, L. Cenarro, A. Jarauta, E. Mateo-Gallego, R. Iotova, V. Tankova, T. Usheva, N. Tsochev, K. Chakarova, N. Galcheva, S. Dimova, R. Bocheva, Y. Radkova, Z. Marinova, V. Bazdarska, Y. Stefanova, T. Rurik, I. Ungvari, T. Jancsó, Z. Nánási, A. Kolozsvári, L. Semánova, C. Bíró, É. Antal, E. Radó, S. Martinez, R. Tong, M. Feel4Diabetes Study Group

Subjects
education
Abstract

Background: Shared risk factors of type 2 diabetes mellitus (T2DM) between parents at risk and their children, such as low physical activity levels, should be addressed to prevent the development of the disease. The aim of this study was to determine the association of objectively measured step counts per day between parents at risk of developing T2DM and their 6- to 10-year-old children. Methods: The baseline data from the Feel4Diabetes study were analyzed. Dyads of children and one parent (n = 250, 54.4% girls and 77.6% mothers) from Belgium were included. Step counts per day during 5 consecutive days from parents and their children were objectively measured with ActiGraph accelerometers. Results: Adjusted linear regression models indicated that parents’ and children’s step counts were significantly associated during all days (β = 0.245), weekdays (β = 0.205), and weekend days (β = 0.316) (P ≤ .002 in all cases). Specifically, mother–daughter associations during all days and weekend days and father–son step counts during weekdays and when considering all days were significant. Conclusion: There is a positive association between step counts from adults at risk of developing T2DM and their children, especially in the mother–daughter and father–son dyads. © 2021 Human Kinetics, Inc.

Published
2021

32. Longitudinal associations between food parenting practices and dietary intake in children: The feel4diabetes study

Author

Flores-Barrantes, P. Iglesia, I. Cardon, G. Willems, R. Schwarz, P. Timpel, P. Kivelä, J. Wikström, K. Iotova, V. Tankova, T. Usheva, N. Rurik, I. Antal, E. Liatis, S. Makrilakis, K. Karaglani, E. Manios, Y. Moreno, L.A. González-Gil, E.M. Feel4Diabetes-Study Group

Abstract

Food parenting practices (FPPs) have an important role in shaping children’s dietary be-haviors. This study aimed to investigate cross-sectional and longitudinal associations over a two-year follow-up between FPP and dietary intake and compliance with current recommendations in 6-to 11-year-old European children. A total of 2967 parent-child dyads from the Feel4Diabetes study, a randomized controlled trial of a school and community-based intervention, (50.4% girls and 93.5% mothers) were included. FPPs assessed were: (1) home food availability; (2) parental role modeling of fruit intake; (3) permissiveness; (4) using food as a reward. Children’s dietary intake was assessed through a parent-reported food frequency questionnaire. In regression analyses, the strongest cross-sectional associations were observed between home availability of 100% fruit juice and corresponding intake (β = 0.492 in girls and β = 0.506 in boys, p < 0.001), and between parental role modeling of fruit intake and children’s fruit intake (β = 0.431 in girls and β = 0.448 in boys, p < 0.001). In multilevel logistic regression models, results indicated that improvements in positive FPPs over time were mainly associated with higher odds of compliance with healthy food recommenda-tions, whereas a decrease in negative FPP over time was associated with higher odds of complying with energy-dense/nutrient-poor food recommendations. Improving FPPs could be an effective way to improve children’s dietary intake. © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Published
2021

33. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes

Author

Wiviott S. D., Raz I., Bonaca M. P., Mosenzon O., Kato E. T., Cahn A., Silverman M. G., Zelniker T. A., Kuder J. F., Murphy S. A., Bhatt D. L., Leiter L. A., McGuire D. K., Wilding J. P. H., Ruff C. T., Nilsson G. I., Fredriksson M., Johansson P. A., Langkilde A. M., Sabatine M. S., Bansilal S., Furtado R., Fish M. P., Gabovitch D., Jevne A., Ahern S., Im K., Goodrich E. L., Lowe C., Fisher N., Gannon J., Trindade S., Towarowski A., Fox Y., Johnsson E., Ranft S., Faber B., Wallander M., Weiss A., Buskila A., Abola M. T. B., Ardissino D., Averkov O., Aylward P., Bode C., Bonnici F., Bonora E., Budaj A. J., Cernea S., Chiang C. E., Cooper M., Dalby A., Deerochanawong C., Dellborg M., Diaz R., Dimulescu D., Eliaschewitz F. G., Goudev A. R., Hadjadj S., Herrera M., Huo Y., Jermendy G., Ji L., Kadowaki T., Kiss R., Kooy A., Kumar K. M. P., Lewis B., Litwak L., Lopez-Sendon J., Ma R., Merlini P. A., Nauck M. A., Nguyen T. K., Nicolau J. C., Ostgren C. J., Ophuis T. O., Padilla F., Pais P., Park K. S., Parkhomenko A., Ray K., Rosenstock J., Ruda M., Satman I., Shestakova M., Smahelova A., Spinar J., Strojek K., Sy R., Tankova T., Theroux P., Tkac I., Van Gaal L., Wainstein J., Harrington R. A., Droller M. J., Lee K. L., Nesto R. W., Tuomilehto J., Hedlin H., Desai M., Sayfer I., Alexanian S., Awtry E., Bentley-Lewis R., Berger C. J., Croce K., Desai A., Garg R. K., Gelfand E., Gignac G., Goessling W., Ho C., Hochberg E., Lane A., Larrey D., Leeman D. E., Lewis J., Link M. S., McDonnell M. E., Norden A. D., Pande A., Rosenberg C., Rost N., Ruberg F., Schiff E., Silverman S., Singhal A., Wagner A., Wolpin B., Aizenberg D., Fernandez M., Sala J., Maffei L., Luquez C., Waitman J., Rista L., Nardone L., Sposetti G., Cantero M., Alvarisqueta A., Montana O., Cuadrado J., Cartasegna L., Baccaro C., Chertkoff A., Sanabria H., Vainstein N., Amerena J., Arya K., d'Emden M., Proietto J., Moses R., Colquhoun D., Stranks S., Lehman R., Hamilton A., Whelan A., Simpson R., Purnell P., Abhayaratna W., Hammett C., McKeirnan M., Sullivan D., Bach L., Hughes K., Mathieu C., Vercammen C., Scheen A., Duyck F., Cools F., De Wolf L., Verhaegen A., Nobels F., Missault L., Crenier L., Thoeng J., Wollaert B., Vandenbroucke M., Eliaschewitz F., Borges J. L. C., Turatti L., Lima F. G., dos Santos F., Kerr Saraiva J., Pereira M., Pereira A., Precoma D. B., Filho G. F. V., Reis G., Maia L. 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J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. 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C, Wee, J, Mirasol, R, Panelo, A, Roxas, D, Palmes, P, Silva, A, Salvador, D, Rosita, R, Maravilla, L, Rogelio, G, Pacheco, E, Tin Hay, L, Prado, J, Krzyzagorska, E, Witek, R, Miklaszewicz, B, Sudnik, W, Pomiecko, W, Bochenek, A, Fares, I, Wujkowski, M, Korol, M, Powierza, S, Goch, A, Miekus, P, Siegel, A, Skierkowska, J, Romanczuk, P, Cygler, J, Landa, K, Szyprowska, E, Stachlewski, P, Czerski, T, Pawlowicz, L, Sowinski, D, Romanowski, L, Rudzki, H, Skorski, M, Jasiel-Wojculewicz, H, Stasiewski, A, Kania, G, Mirek-Bryniarska, E, Wojnowski, L, Korzeniak, R, Oh, T, Lee, M, Jang, H, Kim, S, Ku, B, Cha, B, Son, H, Lee, I, Park, J, Yu, S, Shon, H, Rhee, E, Cho, J, Park, T, Nam, J, Pintilei, E, Popescu, A, Nafornita, V, Gutu, O, Dumitrescu, A, Bala, C, Caceaune, E, Mindrescu, N, Morosanu, M, Bradescu, O, Munteanu, M, Voitec, M, Vlaiculescu, M, Hancu, N, Diaconu Sotropa, M, Lupu, S, Mateescu, A, Carlan, L, Marton, R, Lupusoru, D, Mot, A, Coman, A, Zaharie, D, Rebrov, A, Shutemova, E, Bolieva, L, Khalimov, Y, Statsenko, M, Galyavich, A, Koziolova, N, Shapovalova, Y, Pavlysh, E, Strongin, L, Vertkin, A, Vishneva, E, Pavlova, M, Khasanov, N, Antsiferov, M, Gavrisheva, I, Sokolova, N, Vorobyev, S, Morugova, T, Sinitsina, I, Ezhov, A, Kobalava, Z, Belenkiy, D, Supryadkina, T, Kazakov, Y, Oschepkova, E, Dreval, A, Novikova, T, Vishnevsky, A, Chizhov, D, Akatova, E, Vorokhobina, N, Ivanov, I, Dudinskaya, E, Konstantinov, V, Kanderkova, D, Pavlik, L, Raslova, K, Paulovic, V, Babikova, J, Belesova, K, Merciakova, M, Truban, J, Vargova, A, Fabryova, L, Slovenska, M, Plasil, R, Tomasova, L, Kollarova, D, Spodniakova, D, Kosikova, M, Dzuponova, J, Kurcova, I, Skripova, D, Gabrisova, A, Kalinova, S, Ranjith, N, Burgess, L, Mitha, I, Conradie, M, Distiller, L, Pillai, P, Pillay, S, Horak, A, Nethononda, R, van den Berg, E, Nortje, H, Bayat, J, Corbett, C, Abelson, M, van Zyl, L, Pillay, T, Wing, J, Kapp, C, Hidalgo Urbano, R, Gonzalez Juanatey, J, Blanco Coronado, J, Bruguera Cortada, J, Ferreiro Gutierrez, J, Quesada Simon, M, Castro, A, Delgado Alvarez, E, Freixa, R, Boada, A, Larnefeldt, H, Mooe, T, Koskinen, P, Lagerback, P, Linderfalk, C, Liu, B, Berndtsson Blom, K, Tengmark, B, Lindholm, C, Oweling, M, Albertsson, P, Alvarsson, M, Fant, S, Berglund, O, Hsia, C, Fang, C, Ueng, K, Wang, K, Lai, W, Mamanasiri, S, Wongvipaporn, C, Kuanprasert, S, Thongsri, T, Srimahachota, S, Boonyavarakul, A, Suwanwalaikorn, S, Tantiwong, P, Sritara, P, Sriwijitkamol, A, Sanguanwong, S, Chotinaiwattarakul, C, Piyayotai, D, Balci, M, Orbay, E, Saygili, F, Oguz, A, Altuntas, Y, Comlekci, A, Karpenko, O, Tkach, S, Vlasenko, M, Fushtey, I, Pertseva, T, Reshotko, D, Mostovoy, Y, Vizir, V, Kraiz, I, Amosova, K, Batushkin, V, Tseluyko, V, Koval, O, Strang, C, Bodalia, B, Pieters, R, Turner, W, Asamoah-Owusu, N, White, C, Calvert, J, Mcnally, D, Jones, N, Mckaig, G, Thompson, J, Mohr, S, Simpson, H, Conn, P, Mccoye, A, Rivero, O, Yazdani, S, Ince, C, Zeitlin, J, Wharton, T, Platt, G, Anderson, R, Angueira-Serrano, E, Lillestol, M, Hanlon, B, Soufer, J, Garcia, B, Iteld, B, Venugopal, C, Ahmed, A, Duardo-Guerra, Y, Jetty, P, Miranda, A, Wahlen, J, Lederman, S, Cohen, K, Lake, L, French, W, Tahirkheli, N, Baker, S, Stoltz, R, Wilson, J, Nadar, V, Brown, J, Larrain, G, Wiseman, A, Ruoff, G, Williams, M, Tan, A, Hartman, I, Singh, N, Graf, R, Wakefield, P, Mcneill, R, Byars, W, Reyes Almodovar, R, Jones, S, Kantaros, L, Hegedosh, N, Graves, M, Bernstein, M, Falkowski, S, Bialow, M, Paraschos, A, Dagher, G, Arif, A, Condit, J, Chaykin, L, Grunstra, B, Earl, J, Unks, D, Srivastava, S, Benson, M, Huffman, C, Miller, G, Willis, J, Bender, K, Martin, E, Blackmore, R, Rohr, K, Chilka, S, Gadowski, G, Fitz-Patrick, D, Benjamin, S, Morin, D, Zias Dilena, A, Acosta, R, Claassen, D, Miranda, F, Raad, G, Inzerello, A, Porter, J, Bhattacharya, A, Gutmann, J, Korpas, D, Syed, M, Zieve, F, Raisinghani, A, Alam, S, Bartkowiak, A, Boccalandro, F, Talano, J, Mercado, A, Krichmar, P, Oldfield, C, Adams, K, Gorman, T, Lewis, D, Shah, R, Shockey, G, Lefebvre, G, Andrawis, N, Tami, L, Bittar, N, Khan, M, Rink, L, Hendrix, E, Wood, J, Robinson, J, Pavon, H, Irfan, M, Gonzalez, E, Singal, R, Shore, K, Saba, F, Bianco, J, Erickson, B, Gorson, D, Puri, S, Arauz-Pacheco, C, Forman, S, Akyea-Djamson, A, Lieber, I, Barker, B, Desai, P, Sotolongo, C, Steinhoff, J, Hill, R, Radin, M, Patel, R, Lieberman, S, Wenocur, H, Dagogo-Jack, S, Lupovitch, S, Ison, R, Bacharach, J, Diogo, J, Mazzella, M, Greenwald, J, Quadrel, M, Mayer, N, Datu, J, Mccartney, M, Bruce, T, Singal, D, Turner, J, Videau, B, Fritz, R, Fox, D, Calatayud, G, Sheldon, W, Kereiakes, D, Thomas, J, Salacata, A, Mccullum, K, Harris, B, de Souza, J, Rahman, A, Blumenthal, S, Narayan, P, Bloch, M, Augenbraun, C, Bernstein, R, Perlman, R, Berman, J, Labryer, L, Wynne, A, Fish, J, Zarich, S, Gabra, N, Popeil, L, Hermany, P, Barreto, A, Pomposini, D, Gonzalez-Campoy, J, Langer, M, Bayron, C, Suneja, R, Kamlet, J, Wheeler, K, Hurley, S, Sharma, S, Wefald, F, Hershon, K, O'Connor, T, Pueblitz, G, Laguerre, J, Amin, M, Alfonso, T, Jaffrani, N, Isserman, S, Portnay, E, Vlastaris, A, Dy, J, Hagan, M, Noveck, H, Kraft, P, Andersen, J, Foley, B, Carr, K, Gelormini, J, Williams, T, Landau, C, Richwine, R, Thakkar, M, Karim, A, Madhun, Z, Francyk, D, Lamantia, J, Baker, B, Zhang, W, Lev, V, Hasan, M, Captain, A, Herzog, W, Friedman, K, Lawson, W, Desai, V, Ow, C, Simons, R, Mandviwala, M, Le, T, Hack, T, Zebrack, J, Henderson, D, Dejulia, J, Mehta, R, Reza, S, Poonawala, R, Awad, A, Velasquez, M, Mohiuddin, S, Salazar Sharma, M, Myrick, G, Gottlieb, D, Ovalle, F, Alfieri, A, Ahmed, S, Bohula, E, Donahoe, S, Longshaw, K, Eshaghian, S, Lash, J, Goldberg, R, Fox, B, Mostel, E, Dobies, D, Ward, H, Burbano, J, Puleo, P, Lenhard, M, Korn, D, Thadani, U, Bradley, A, Kmetzo, J, Heasley, E, Raikhel, M, Mahr, N, Bittar, G, Fuentes, F, Raghu, P, Diep, T, Tran, Q, Tran, N, Nguyen, D, and Nguyen, V

Subjects
Male, medicine.medical_specialty, dapagliflozin, placebo, [SDV]Life Sciences [q-bio], Renal function, Type 2 diabetes, [SDV.BC]Life Sciences [q-bio]/Cellular Biology, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Glucosides, Diabetes mellitus, Internal medicine, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Benzhydryl Compounds, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, ComputingMilieux_MISCELLANEOUS, Aged, Heart Failure, Canagliflozin, business.industry, [SDV.BA]Life Sciences [q-bio]/Animal biology, General Medicine, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, Hospitalization, Diabetes Mellitus, Type 2, chemistry, Cardiovascular Diseases, Heart failure, Cardiology, Female, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Mace, medicine.drug
Abstract

BACKGROUND The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to ≥60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], ≥1.3; P≥0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P = 0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P = 0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93; 95% CI, 0.82 to 1.04). Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3%vs. 0.1%, P = 0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. 0.1%, P≥0.001). CONCLUSIONS In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. (Funded by AstraZeneca; DECLARETIMI 58 ClinicalTrials.gov number, NCT01730534

Published
2019

34. Lifestyle changes observed among adults participating in a family-and community-based intervention for diabetes prevention in Europe: The 1st year results of the feel4diabetes-study

Author

Manios, Y., Lambrinou, C.P., Mavrogianni, C., Cardon, G., Lindström, J., Iotova, V., Tankova, T., Rurik, I., Van Stappen, V., Kivelä, J., Mateo-Gallego, R., Moreno, L.A., Makrilakis, K., Androutsos, O., and Feel4Diabetes-study, group

Abstract

The Feel4Diabetes intervention was a school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes (T2D) among families at risk of developing this disease. The current study aims to present the results on lifestyle behaviors obtained from parents during the first year of the Feel4Diabetes intervention. This multicomponent intervention had a cluster randomized design and was implemented in Belgium, Bulgaria, Finland, Greece, Hungary and Spain over two years (2016–2018). Standardized protocols and procedures were used by the participating centers in all countries to collect data on parents’ lifestyle behaviors (diet, physical activity, sedentary behavior). The Feel4Diabetes intervention was registered at clinicaltrials.gov (registration number: NCT02393872). In total, 2110 high-risk parents participated in the baseline and 12-month follow-up examination measurements. Participants allocated to the intervention group reduced their daily consumption of sugary drinks (p = 0.037) and sweets (p = 0.031) and their daily screen time (p = 0.032), compared with the control group. In addition, participants in the intervention group in Greece and Spain increased their consumption of breakfast (p = 0.034) and fruits (p = 0.029), while in Belgium and Finland they increased their water intake (p = 0.024). These findings indicate that.

Published
2020

35. Obtaining evidence base for the development of Feel4Diabetes intervention to prevent type 2 diabetes- A narrative literature review

Author

Kivelä, J., Wikström, K., Virtanen, E., Georgoulis, M., Cardon, G., Civeira, F., Iotova, V., Karuranga, E., Ko, W., Liatis, S., Makrilakis, K., Manios, Y., Mateo-Gallego, R., Nanasi, A., Rurik, I., Tankova, T., Tsochev, K., Van Stappen, V., and Lindström, J.

Abstract

Background: Feel4Diabetes was a school and community based intervention aiming to promote healthy lifestyle and tackle obesity for the prevention of type 2 diabetes among families in 6 European countries. We conducted this literature review in order to guide the development of evidence-based implementation of the Feel4Diabetes intervention. We focused on type 2 diabetes prevention strategies, including all the phases from risk identification to implementation and maintenance. Special focus was given to prevention among vulnerable groups and people under 45 years. Methods: Scientific and grey literature published between January 2000 and January 2015 was searched for relevant studies using electronic databases. To present the literature review findings in a systematic way, we used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A complementary literature search from February 2015 to December 2018 was also conducted. Results: The initial review included 27 studies with a follow-up =12 months and 9 studies with a follow-up =6 months and with a participant mean age < 45 years. We found out that interventions should be targeted at people at risk to improve recruiting and intervention effectiveness. Screening questionnaires (primarily Finnish Diabetes Risk Score FINDRISC) and blood glucose measurement can both be used for screening; the method does not appear to affect intervention effectiveness. Screening and recruitment is time-consuming, especially when targeting lower socioeconomic status and age under 45 years. The intervention intensity is more important for effectiveness than the mode of delivery. Moderate changes in several lifestyle habits lead to good intervention results. A minimum of 3-year follow-up seemed to be required to show a reduction in diabetes risk in high-risk individuals. In participants < 45 years, the achieved results in outcomes were less pronounced. The complementary review included 12 studies, with similar results regarding intervention targets and delivery modes, as well as clinical significance. Conclusion: This narrative review highlighted several important aspects that subsequently guided the development of the Feel4Diabetes high-risk intervention. Research on diabetes prevention interventions targeted at younger adults or vulnerable population groups is still relatively scarce. Feel4Diabetes is a good example of a project aiming to fill this research gap.

Published
2020

36. Obtaining evidence base for the development of Feel4Diabetes intervention to prevent type 2 diabetes- A narrative literature review

Author

Kivelä, J. Wikström, K. Virtanen, E. Georgoulis, M. Cardon, G. Civeira, F. Iotova, V. Karuranga, E. Ko, W. Liatis, S. Makrilakis, K. Manios, Y. Mateo-Gallego, R. Nanasi, A. Rurik, I. Tankova, T. Tsochev, K. Van Stappen, V. Lindström, J.

Abstract

Background: Feel4Diabetes was a school and community based intervention aiming to promote healthy lifestyle and tackle obesity for the prevention of type 2 diabetes among families in 6 European countries. We conducted this literature review in order to guide the development of evidence-based implementation of the Feel4Diabetes intervention. We focused on type 2 diabetes prevention strategies, including all the phases from risk identification to implementation and maintenance. Special focus was given to prevention among vulnerable groups and people under 45 years. Methods: Scientific and grey literature published between January 2000 and January 2015 was searched for relevant studies using electronic databases. To present the literature review findings in a systematic way, we used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A complementary literature search from February 2015 to December 2018 was also conducted. Results: The initial review included 27 studies with a follow-up ≥12 months and 9 studies with a follow-up ≥6 months and with a participant mean age < 45 years. We found out that interventions should be targeted at people at risk to improve recruiting and intervention effectiveness. Screening questionnaires (primarily Finnish Diabetes Risk Score FINDRISC) and blood glucose measurement can both be used for screening; the method does not appear to affect intervention effectiveness. Screening and recruitment is time-consuming, especially when targeting lower socioeconomic status and age under 45 years. The intervention intensity is more important for effectiveness than the mode of delivery. Moderate changes in several lifestyle habits lead to good intervention results. A minimum of 3-year follow-up seemed to be required to show a reduction in diabetes risk in high-risk individuals. In participants < 45 years, the achieved results in outcomes were less pronounced. The complementary review included 12 studies, with similar results regarding intervention targets and delivery modes, as well as clinical significance. Conclusion: This narrative review highlighted several important aspects that subsequently guided the development of the Feel4Diabetes high-risk intervention. Research on diabetes prevention interventions targeted at younger adults or vulnerable population groups is still relatively scarce. Feel4Diabetes is a good example of a project aiming to fill this research gap. Trial registration: Clinicaltrials.gov NCT02393872, registered 20th March 2015. © 2020 The Author(s).

Published
2020

37. Feel4Diabetes healthy diet score: Development and evaluation of clinical validity

Author

Virtanen, E. Kivelä, J. Wikström, K. Lambrinou, C.-P. De Miguel-Etayo, P. Huys, N. Vraukó-Tóth, K. Moreno, L.A. Usheva, N. Chakarova, N. Rado, S.A. Iotova, V. Makrilakis, K. Cardon, G. Liatis, S. Manios, Y. Lindström, J. Manios, Y. Cardon, G. Lindström, J. Schwarz, P. Makrilakis, K. Annemans, L. Garamendi, I. Karatzi, K. Androutsos, O. Moschonis, G. Kanellakis, S. Mavrogianni, C. Tsoutsoulopoulou, K. Katsarou, C. Karaglani, E. Qira, I. Skoufas, E. Maragkopoulou, K. Tsiafitsa, A. Sotiropoulou, I. Tsolakos, M. Argyri, E. Nikolaou, M. Vampouli, E.-A. Filippou, C. Apergi, K. Filippou, A. Katerina, G. Dimitriadis, E. Laatikainen, T. Wikström, K. Kivelä, J. Valve, P. Levälahti, E. Virtanen, E. Pennanen, T. Olli, S. Nelimarkka, K. Van Stappen, V. Huys, N. Willems, R. Shadid, S. Timpel, P. Liatis, S. Dafoulas, G. Lambrinou, C.-P. Giannopoulou, A. Rabemananjara, L. De Sabata, M.S. Ko, W. Civeira, F. Bueno, G. De Miguel-Etayo, P. Gonzalez-Gil, E.Mª. Miguel-Berges, M.L. Giménez-Legarre, N. Flores-Barrantes, P. Ayala-Marín, A.M. Seral-Cortés, M. Baila-Rueda, L. Cenarro, A. Jarauta, E. Mateo-Gallego, R. Iotova, V. Tankova, T. Usheva, N. Tsochev, K. Chakarova, N. Galcheva, S. Dimova, R. Bocheva, Y. Radkova, Z. Marinova, V. Bazdarska, Y. Stefanova, T. Rurik, I. Ungvari, T. Jancsó, Z. Nánási, A. Kolozsvári, L. Semánova, C. Bíró, É. Antal, E. Radó, S. Martinez, R. Tong, M. Feel4Diabetes research group

Abstract

Background: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. Methods: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson's correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson's correlations were studied between baseline and 1 year score, within the control group only. Results: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p < 0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. Conclusion: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner. Trial registration: Clinicaltrials.gov NCT02393872. Registered March 20, 2015. © 2020 The Author(s).

Published
2020

38. Feel4Diabetes healthy diet score: Development and evaluation of clinical validity

Author

Virtanen, E., Kivelä, J., Wikström, K., Lambrinou, C.P., De Miguel-Etayo, P., Huys, N., Vraukó-Tóth, K., Moreno, L.A., Usheva, N., Chakarova, N., Rado, S.A., Iotova, V., Makrilakis, K., Cardon, G., Liatis, S., Manios, Y., Lindström, J., Schwarz, P., Annemans, L., Garamendi, I., Karatzi, K., Androutsos, O., Moschonis, G., Kanellakis, S., Mavrogianni, C., Tsoutsoulopoulou, K., Katsarou, C., Karaglani, E., Qira, I., Skoufas, E., Maragkopoulou, K., Tsiafitsa, A., Sotiropoulou, I., Tsolakos, M., Argyri, E., Nikolaou, M., Vampouli, E.A., Filippou, C., Apergi, K., Filippou, A., Katerina, G., Dimitriadis, E., Laatikainen, T., Valve, P., Levälahti, E., Pennanen, T., Olli, S., Nelimarkka, K., Van Stappen, V., Willems, R., Shadid, S., Timpel, P., Dafoulas, G., Giannopoulou, A., Rabemananjara, L., De Sabata, M.S., Ko, W., Moreno, L., Civeira, F., Bueno, G., Gonzalez-Gil, E.Mª., Miguel-Berges, M.L., Giménez-Legarre, N., Flores-Barrantes, P., Ayala-Marín, A.M., Seral-Cortés, M., Baila-Rueda, L., Cenarro, A., Jarauta, E., Mateo-Gallego, R., Tankova, T., Tsochev, K., Galcheva, S., Dimova, R., Bocheva, Y., Radkova, Z., Marinova, V., Bazdarska, Y., Stefanova, T., Rurik, I., Ungvari, T., Jancsó, Z., Nánási, A., Kolozsvári, L., Semánova, C., Bíró, É., Antal, E., Radó, S., Martinez, R., Tong, M., and Feel4Diabetes, research, group

Abstract

Background: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. Methods: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson''s correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson''s correlations were studied between baseline and 1 year score, within the control group only. Results: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p < 0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. Conclusion: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner.

Published
2020

39. Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: The Feel4Diabetes-study

Author

Manios, Y. Mavrogianni, C. Lambrinou, C.-P. Cardon, G. Lindström, J. Iotova, V. Tankova, T. Civeira, F. Kivelä, J. Jancsó, Z. Shadid, S. Tsochev, K. Mateo-Gallego, R. Radó, S. Dafoulas, G. Makrilakis, K. Androutsos, O.

Abstract

Background: The implementation of population screening and early prevention strategies targeting individuals at high-risk for type 2 diabetes (T2D) seems to be a public health priority. The current work aimed to describe the screening procedure applied in the Feel4Diabetes-study and examine its effectiveness in identifying individuals and families at high risk, primarily for T2D and secondarily for hypertension, among vulnerable populations in low to middle-income countries (LMICs) and high-income countries (HICs) across Europe. Methods: A two-stage screening procedure, using primary schools as the entry-point to the community, was applied in low socioeconomic status (SES) regions in LMICs (Bulgaria-Hungary), HICs (Belgium-Finland) and HICs under austerity measures (Greece-Spain). During the first-stage screening via the school-setting, a total of 20,501 parents (mothers and/or fathers) of schoolchildren from 11,396 families completed the Finnish Diabetes Risk Score (FINDRISC) questionnaire, while their children underwent anthropometric measurements in the school setting. Parents from the identified "high-risk families" (n = 4484) were invited to participate in the second-stage screening, including the measurement of fasting plasma glucose (FPG) and blood pressure (BP). In total, 3153 parents participated in the second-stage screening (mean age 41.1 ± 5.6 years, 65.8% females). Results: Among parents who attended the second-stage screening, the prevalence of prediabetes (as defined by impaired fasting glucose; FPG 100-125 mg/dl) and T2D (FPG > 126 mg/dl) was 23.2 and 3.0% respectively, and it was found to be higher in the higher FINDRISC categories. The percentage of undiagnosed T2D among the participants identified with T2D was 53.5%. The prevalence of high normal BP (systolic BP 130-139 mmHg and/or diastolic BP 85-89 mmHg) and hypertension (systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) was 14 and 18.6% respectively, which was also higher in the higher FINDRISC categories. The percentage of cases not receiving antihypertensive treatment among the participants identified with hypertension was 80.3%. Conclusion: The findings of the current study indicate that the two-stage school and community-based screening procedure followed, effectively identified high-risk individuals and families in vulnerable populations across Europe. This approach could be potentially scalable and sustainable and support initiatives for the early prevention of T2D and hypertension. Trial registration: The Feel4Diabetes-intervention is registered at http://clinicaltrials.gov/(NCT02393872; date of trial registration: March 20, 2015). © 2020 The Author(s).

Published
2020

40. Microvascular and cardiovascular outcomes according to renal function in patients treated with once-weekly exenatide: Insights from the EXSCEL trial

Author

Jakuboniene, N., Maggioni, A.P., Angelyn Bethel, M., Goodman, S.G., Ohman, P., Chan, J.C., Buse, J.B., Lopes, R.D., Mentz, R.J., Holman, R.R., Merrill, P., Hernandez, A.F., Lokhnygina, Y., Katona, B., Bakris, G.L., Iqbal, N., and Tankova, T.

Subjects
urologic and male genital diseases
Abstract

OBJECTIVE To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). RESEARCH DESIGN AND METHODS Least squares mean difference (LSMD) in estimated glomerular filtration rate (eGFR) from baseline between the EQW and placebo groups was calculated for 13,844 participants. Cox regression models were used to estimate effects by group on incident macroalbuminuria, retinopathy, and major adverse CV events (MACE). Interval-censored time-to-event models estimated effects on renal composite 1 (40% eGFR decline, renal replacement, or renal death) and renal composite 2 (composite 1 variables plus macroalbuminuria). RESULTS EQW did not change eGFR significantly (LSMD 0.21 mL/min/1.73 m2 [95% CI 20.27 to 0.70]). Macroalbuminuria occurred in 2.2% of patients in the EQW group and in 2.5% of those in the placebo group (hazard ratio [HR] 0.87 [95% CI 0.70-1.07]). Neither renal composite was reduced with EQW in unadjusted analyses, but renal composite 2 was reduced after adjustment (HR 0.85 [95% CI 0.74-0.98]). Retinopathy rates did not differ by treatment group or in the HbA1c-lowering or prior retinopathy subgroups. CV outcomes in those with eGFR

Published
2020
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41. Sociodemographic and lifestyle-related risk factors for identifying vulnerable groups for type 2 diabetes: A narrative review with emphasis on data from Europe

Author

Kyrou, I. Tsigos, C. Mavrogianni, C. Cardon, G. Van Stappen, V. Latomme, J. Kivelä, J. Wikström, K. Tsochev, K. Nanasi, A. Semanova, C. Mateo-Gallego, R. Lamiquiz-Moneo, I. Dafoulas, G. Timpel, P. Schwarz, P.E.H. Iotova, V. Tankova, T. Makrilakis, K. Manios, Y.

Subjects
endocrine system diseases, nutritional and metabolic diseases
Abstract

Background: Type 2 diabetes mellitus (T2DM) comprises the vast majority of all diabetes cases in adults, with alarmingly increasing prevalence over the past few decades worldwide. A particularly heavy healthcare burden of diabetes is noted in Europe, where 8.8% of the population aged 20-79 years is estimated to have diabetes according to the International Diabetes Federation. Multiple risk factors are implicated in the pathogenesis of T2DM with complex underlying interplay and intricate gene-environment interactions. Thus, intense research has been focused on studying the role of T2DM risk factors and on identifying vulnerable groups for T2DM in the general population which can then be targeted for prevention interventions. Methods: For this narrative review, we conducted a comprehensive search of the existing literature on T2DM risk factors, focusing on studies in adult cohorts from European countries which were published in English after January 2000. Results: Multiple lifestyle-related and sociodemographic factors were identified as related to high T2DM risk, including age, ethnicity, family history, low socioeconomic status, obesity, metabolic syndrome and each of its components, as well as certain unhealthy lifestyle behaviors. As Europe has an increasingly aging population, multiple migrant and ethnic minority groups and significant socioeconomic diversity both within and across different countries, this review focuses not only on modifiable T2DM risk factors, but also on the impact of pertinent demographic and socioeconomic factors. Conclusion: In addition to other T2DM risk factors, low socioeconomic status can significantly increase the risk for prediabetes and T2DM, but is often overlooked. In multinational and multicultural regions such as Europe, a holistic approach, which will take into account both traditional and socioeconomic/socioecological factors, is becoming increasingly crucial in order to implement multidimensional public health programs and integrated community-based interventions for effective T2DM prevention. © 2020 The Author(s).

Published
2020

42. Sociodemographic and lifestyle-related risk factors for identifying vulnerable groups for type 2 diabetes: A narrative review with emphasis on data from Europe

Author

Kyrou, I., Tsigos, C., Mavrogianni, C., Cardon, G., Van Stappen, V., Latomme, J., Kivelä, J., Wikström, K., Tsochev, K., Nanasi, A., Semanova, C., Mateo-Gallego, R., Lamiquiz-Moneo, I., Dafoulas, G., Timpel, P., Schwarz, P.E.H., Iotova, V., Tankova, T., Makrilakis, K., and Manios, Y.

Subjects
endocrine system diseases, nutritional and metabolic diseases
Abstract

Background: Type 2 diabetes mellitus (T2DM) comprises the vast majority of all diabetes cases in adults, with alarmingly increasing prevalence over the past few decades worldwide. A particularly heavy healthcare burden of diabetes is noted in Europe, where 8.8% of the population aged 20-79 years is estimated to have diabetes according to the International Diabetes Federation. Multiple risk factors are implicated in the pathogenesis of T2DM with complex underlying interplay and intricate gene-environment interactions. Thus, intense research has been focused on studying the role of T2DM risk factors and on identifying vulnerable groups for T2DM in the general population which can then be targeted for prevention interventions. Methods: For this narrative review, we conducted a comprehensive search of the existing literature on T2DM risk factors, focusing on studies in adult cohorts from European countries which were published in English after January 2000. Results: Multiple lifestyle-related and sociodemographic factors were identified as related to high T2DM risk, including age, ethnicity, family history, low socioeconomic status, obesity, metabolic syndrome and each of its components, as well as certain unhealthy lifestyle behaviors. As Europe has an increasingly aging population, multiple migrant and ethnic minority groups and significant socioeconomic diversity both within and across different countries, this review focuses not only on modifiable T2DM risk factors, but also on the impact of pertinent demographic and socioeconomic factors. Conclusion: In addition to other T2DM risk factors, low socioeconomic status can significantly increase the risk for prediabetes and T2DM, but is often overlooked. In multinational and multicultural regions such as Europe, a holistic approach, which will take into account both traditional and socioeconomic/socioecological factors, is becoming increasingly crucial in order to implement multidimensional public health programs and integrated community-based interventions for effective T2DM prevention.

Published
2020

43. Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review

Author

Janež, A. Guja, C. Mitrakou, A. Lalic, N. Tankova, T. Czupryniak, L. Tabák, A.G. Prazny, M. Martinka, E. Smircic-Duvnjak, L.

Abstract

Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin < 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared with older basal insulins include reduced injection burden, better efficacy, lower risk of hypoglycemic episodes (especially nocturnal), and reduced weight gain. For prandial glycemic control, any rapid-acting prandial analogue (aspart, glulisine, lispro) is preferred over regular human insulin. Faster-acting insulin aspart is a relatively new option with the advantage of better postprandial glucose coverage. Frequent blood glucose measurements along with patient education on insulin dosing based on carbohydrate counting, premeal blood glucose, and anticipated physical activity is paramount, as is education on the management of blood glucose under different circumstances. Plain Language Summary: Plain language summary is available for this article. © 2020, The Author(s).

Published
2020

44. Effective strategies for childhood obesity prevention via school based, family involved interventions: A critical review for the development of the Feel4Diabetes-study school based component

Author

Lambrinou, C.-P. Androutsos, O. Karaglani, E. Cardon, G. Huys, N. Wikström, K. Kivelä, J. Ko, W. Karuranga, E. Tsochev, K. Iotova, V. Dimova, R. De Miguel-Etayo, P. M. González-Gil, E. Tamás, H. Jancsó, Z. Liatis, S. Makrilakis, K. Manios, Y. Cardon, G. Lindström, J. Schwarz, P. Makrilakis, K. Annemans, L. Garamendi, I. Karatzi, K. Androutsos, O. Moschonis, G. Kanellakis, S. Mavrogianni, C. Tsoutsoulopoulou, K. Katsarou, C. Karaglani, E. Qira, I. Skoufas, E. Maragkopoulou, K. Tsiafitsa, A. Sotiropoulou, I. Tsolakos, M. Argyri, E. Nikolaou, M. Vampouli, E.-A. Filippou, C. Apergi, K. Filippou, A. Katerina, G. Dimitriadis, E. Lindström, J. Laatikainen, T. Wikström, K. Hovi, P. Kivelä, J. Valve, P. Levälahti, E. Virtanen, E. Cardon, G. Van Stappen, V. Huys, N. Annemans, L. Willems, R. Shadid, S. Schwarz, P. Timpel, P. Makrilakis, K. Liatis, S. Dafoulas, G. Lambrinou, C.-P. Giannopoulou, A. Rabemananjara, L. De Sabata, M.S. Ko, W. Garamendi, I. Moreno, L. Civeira, F. Bueno, G. De Miguel-Etayo, P. Gonzalez-Gil, E.Mª. Miguel-Berges, M.L. Giménez-Legarre, N. Flores-Barrantes, P. Ayala-Marín, A.M. Seral-Cortés, M. Baila-Rueda, L. Cenarro, A. Jarauta, E. Mateo-Gallego, R. Iotova, V. Tankova, T. Usheva, N. Tsochev, K. Chakarova, N. Galcheva, S. Dimova, R. Bocheva, Y. Radkova, Z. Marinova, V. Bazdarska, Y. Stefanova, T. Rurik, I. Ungvari, T. Jancsó, Z. Nánási, A. Kolozsvári, L. Semánova, C. Bíró, É. Antal, E. Radó, S. Martinez, R. Tong, M.

Abstract

Background: Although there are many interventions targeting childhood obesity prevention, only few have demonstrated positive results. The current review aimed to gather and evaluate available school-based intervention studies with family involvement targeting dietary, physical activity and sedentary behaviors among primary schoolchildren and their families, in order to identify the most effective strategies. Methods: Studies published between 2000 and January 2015 were retrieved from scientific electronic databases and grey literature. The databases used included MEDLINE/PubMed, Web-of-Science, CINAHL and Scopus. Included studies had to be experimental controlled studies and had duration over 1 school year, had family involvement, combined PA and dietary behaviors and were implemented in school setting. A complementary search was executed to update the review to cover the period from February 2015 to January 2019. Results: From the studies examined (n = 425), 27 intervention programs (33 publications) fulfilled the inclusion criteria. Among these, 15 presented significant effect on weight status and/ or overweight/ obesity or clinical indices, 3 presented significant effect on most energy balance-related behaviors (EBRBs) while 9 presented significant effect on some/few EBRBs or determinants. Strategies implemented in effective interventions were: teachers acting as role-models and being actively involved in the delivery of the intervention, school policies supporting the availability of healthy food and beverage choices and limiting unhealthy snacks, changes in the schoolyard, in the recess rules and in the physical education classes to increase physical activity, and involving parents in the intervention via assignments, meetings, informative material and encouraging them to improve the home environment. Use of incentives for children, social marketing techniques, collaboration with local stakeholders were found to increase effectiveness. Programs that focused only on educational sessions and material for parents, without promoting relevant environmental and policy changes, were found to be less effective. Cultural adaptations have been suggested to increase the intervention's acceptance in specific or vulnerable population groups. Conclusions: Several effective strategies were identified in the reviewed programs. Outcomes of the current review were taken into account in developing the Feel4Diabetes-intervention and summed up as recommendations in the current work in order to facilitate other researchers designing similar childhood obesity prevention initiatives. © 2020 The Author(s).

Published
2020

45. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes

Author

Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR, Josse RG, Califf RM, Goldstein BJ, Shapiro DR, Silverman R, Bethel A, Green J, Hayden S, Hannan K, Quintero K, Rorick T, Berdan L, Leloudis D, Califf S, Wilson M, McFarron D, Trollinger K, Pesarchick J, Eskenazi L, Campbell C, Townes O, Tolsma D, Keenan J, Milton J, Athwal R, Darbyshire J, Doran Z, Kennedy I, Gregory V, Lokhnygina Y, Prather K, Wolfley A, Usman M, Tajjar A, Gray R, Pfeffer MA, Gerstein HC, Groop L, McMurray JJ, Pocock SJ, Clayton T, Sinay I, Brieger D, Stranks S, Scheen A, Lopes R, Tankova T, Hramiak I, Grado CR, Wenying Y, Ge J, Aschner P, Skrha J, Ambos A, Strandberg T, Travert F, Hanefeld M, Riefflin A, Chan JC, Ofner P, Reddy NK, Christopher J, Mathur A, Arambam P, Mittal S, Manchanda M, Wainstein J, Ambrosio G, Pirags V, Jakuboniene N, Mohamed M, Scott R, White H, Cornel J, Halvorsen S, Tykarski A, Veresiu IA, Dreval AV, Misinkova I, Tai E, Krahulec B, Distiller L, Park Y, Rovira A, Alversson M, Chuang LM, Delibasi T, Adler A, Rodbard HW, Marre M, Goff D, Chacra A, DeVore A, Beaven A, Shah B, Hirsch B, Batch B, Bushnell C, Patel C, Melloni C, Henshaw C, Kong D, Bernecki G, Tillman H, Kang HJ, Hawes J, Strickler J, Piccini J, Wilder J, Alexander K, Mahaffey K, Patel K, Hyland K, Newby K, Jackson L, Cooper L, Armaganijan L, Szczeh L, Koshizaka M, Roe M, Morse M, Guimaraes P, Hess P, Tricoci P, Mehta R, Mathews R, Kociol R, Harrison R, Mentz R, Pokorney S, Leblanc T, Lazzarini V, Eapen Z, Truffa A, Fosbol E, Brito F, Katz M, Bahit M, Santos M, Barros P, Bernardez S, Alvarisqueta AF, Arias P, Cagide AL, Calella PR, Cantero MC, Canella JP, Cipullo MA, de Loredo L, Gelersztein ES, Gorban de Lapertosa SB, Klyver MI, Maffei LE, Maldonado N, Oviedo AI, Piskorz DL, Ridruejo MC, Saavedra SS, Sessa HA, Sinay IR, Sposetti GD, Ulla MR, Vico ML, Waitman JN, Binnekamp M, Carroll P, Cheung W, Colman P, Davis T, De Looze F, dEmden M, Fulcher G, Gerstman M, Hamilton A, Lehman S, Moses R, Proietto J, Roberts A, Shaw J, Simpson R, Sinha A, Tan Y, Topliss D, Vora P, Waites J, Crenier L, Descamps O, Keymeulen B, Mathieu C, Nobels F, Van den Bruel A, Van Gaal L, Borges JL, Costa e Forti A, Eliaschewitz FG, Felício JS, Griz LH, Hissa MN, Leite S, Panarotto D, Pimentel Filho P, Rassi N, Saraiva JK, Sgarbi JA, Silva RP, Tambascia M, Weber Silva DM, Bobeva R, Bostandzhieva R, Cinlikov I, Georgieva M, Iliev D, Ilieva E, Kovacheva S, Liubenova L, Nikitov Z, SHeinikova G, Slavcheva A, Spasova V, Temelkova-Kurktschiev T, Velichka D, Yakov A, Carpentier A, Chiasson JL, Constance C, Dumas R, Filteau P, Garceau C, Huynh T, Kaiser S, Kornder J, Leiter L, Mereu L, Miller D, Pandey S, Punthakee Z, Rabasa-Lhoret R, Robitaille Y, Saunders K, Sigal R, Sigalas J, Vizel S, Weisnagel S, Woo V, Yale JF, Yared K, Zinman B, Bunster Balocchi LB, Escobar Cerda EE, Garces Flores EE, Lanas Zanetti FT, Larrazabal Miranda Adel P, Morales Alvarado JM, Olivares Cañon CM, Potthoff Cárdenas SH, Raffo Grado CA, Rodriguez Venegas ME, Saavedra Gajardo VA, Westerberg Maldonado BH, Chen LL, Dong J, Guo X, Li QM, Shi B, Tang XL, Yang T, Yang WY, Zheng SX, Aschner Montoya P, Botero Lopez R, Coronel Arroyo JA, Cure CA, Gómez Medina AM, Molina DI, Perez Amador GA, Reyes Rincon A, Urina Triana MA, Valenzuela Rincon A, Vélez Pelaez S, Yupanqui Lozno H, Brabec T, Brychta T, Hasalova Zapletalova J, Havelkova J, Hejnicova K, Hola O, Hornackova M, Hrdina T, Kafkova D, Kellnerova I, Krystl T, Kutejova V, Mikulkova I, Nevrla J, Pantlikova C, Petr M, Racicka E, Sarbochova R, Smolenakova K, Turcinek R, Urbancova K, Vejvodova J, Vondrakova M, Zachoval R, Alt I, Kaasik Ü, Kiiroja K, Lanno R, Märtsin K, Past M, Vides H, Viitas L, Kantola I, Nieminen S, Perhonen M, Strand J, Valle T, Clergeot A, Couffinhal T, Courreges JP, Gouet D, Moulin P, Ziegler O, Badenhoop K, Behnke T, Bender G, Braun M, Dshabrailov J, Hamann A, Himpel-Boenninghoff A, Kamke W, Kasperk C, Luedemann J, Mayr P, Merkel M, Oerter EM, Ohlow MA, Ott P, Overhoff U, Paschen B, Remppis R, Rose L, Schumm-Draeger PM, Segiet T, Strotmann HJ, Stuchlik G, Stürmer W, Thinesse-Mallwitz M, Tytko A, Wendisch U, Wurziger J, Ho AY, Kam G, Kong AP, Lam YY, Lau EY, Lee S, Siu SC, Tomlinson B, Tsang CC, Yeung VT, Dezső E, Dudás M, Földesi I, Fülöp T, Késmárki N, Koranyi L, Nagy K, Oroszlán T, Pécsvárady Z, Ples Z, Taller A, Agarwal P, Ambulkar S, Aravind S, Balaji V, Kalra S, Kesavadev J, Kudalkar H, Kumar A, Misra A, Mithal A, Mohan V, Pitale S, Ramu M, Reddy N, Shah S, Shamanna P, Sharda A, Sharma A, Shunmugavelu M, Srikanta S, Suryaprakash G, Abramov G, Adawi F, Bashkin A, Darawsha M, Fuchs S, Harman-Boehm I, Hayek T, Jaffe A, Knobler H, Minuchin O, Mosseri M, Shechter M, Shimon I, Stern N, Tsur A, Vishlitzky V, Alfonsi F, Cavalot F, Del Vecchio L, Frisinghelli A, Gambardella S, Lauro D, Lembo G, Leotta S, Mondillo S, Novo S, Pedrinelli R, Piatti P, Salvioni A, Tritto I, Zavaroni DZ, Ahn KJ, Choi KM, Chung C, Han SJ, Kim DM, Kim IJ, Kim MH, Lee IK, Nam M, Park IeB, Park KS, Park TS, Rhee EJ, Yoo SJ, Andersone I, Balode A, Eglite R, Gersamija A, Kakurina N, Jegere B, Leitane I, Pastare S, Stalte V, Teterovska D, Baltramonaitiene K, Barsiene L, Ceponis J, Lasiene J, Levinger A, Sirutaviciene A, Sulskiene M, Urbanaviciene L, Valius L, Varanauskiene E, Velickiene D, Mahendran KA, Abu Hassan MR, Aziz NA, Hussein Z, Ismail IS, Kamaruddin NA, Nordin Z, Nayar SK, Ramanathan GR, Sothiratnam R, Beijerbacht H, Breedveld R, Cornel JH, Den Hartog F, Hermans W, Kietselaer B, Kooy A, Lenderink T, Nierop P, Remmen J, Rojas Lingan G, Ronner E, Van der Heijden R, Van Hessen M, van Kempen W, Voors-Pette C, Westendorp I, Baker J, Benatar J, Cutfield R, Krebs J, Leikis R, Lunt H, Manning P, Williams M, Birkeland K, Claudi T, Istad H, Karlsson T, Ossum Gronert J, Arciszewska M, Artemiuk E, Blach E, Blicharski T, Cypryk K, Dabrowska M, Górny G, Górska M, Jakubowska I, Jazwinska-Tarnawska E, Karczmarczyk A, Kitowska-Koterla J, Koltowski L, Krzyzagorska E, Pasternak D, Pentela-Nowicka J, Piesiewicz W, Przekwas-Jaruchowska M, Rajzer M, Salamon-Ferenc A, Sawicki A, Skowron T, Śmiałowski A, Albota A, Alexandru C, Crisan C, Dumitrescu A, Ferariu IE, Lupusoru DA, Munteanu M, Negru D, Nicolau A, Pintiliei E, Popescu A, Serban G, Voitec M, Babenko A, Barbarash O, Bondar I, Chizhov P, Demin A, Dora S, Dreval A, Ershova O, Gratsiansky N, Ketova G, Kotelnikov M, Levashov S, Morugova T, Mustafina S, Pekarskiy S, Raskina T, Rechkova E, Samoylova Y, Sazonova O, Sherenkov A, Shilkina N, Stetsyuk O, Tretyakova T, Turova E, Valeeva F, Zadionchenko V, Dalan R, Tan RS, Tay L, Buganova I, Fabry J, Jan C, Toserova E, Zak R, Zimanova J, Badat A, Bester F, Burgess L, De Jong D, Ellis G, Fouche L, Govender P, Govind U, Naidoo V, Nieuwoudt G, Nortje H, Rheeder P, Robertson L, Siddique N, Stapelberg AM, 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Subjects
Oral, medicine.medical_specialty, Heart diseases, Glycosylated, Administration, Oral, heart failure, Type 2 diabetes, Dipeptidyl peptidase-4 inhibitor, Kaplan-Meier Estimate, Placebo, Sitagliptin Phosphate, Sitagliptin, Cardiovascular Outcomes, chemistry.chemical_compound, Drug Therapy, Double-Blind Method, Internal medicine, Diabetes Mellitus, medicine, Humans, Hypoglycemic Agents, Glycated Hemoglobin, Hemoglobin A, Glycosylated, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Follow-Up Studies, Heart Diseases, Heart Failure, Hospitalization, Pyrazines, Triazoles, Medicine (all), business.industry, Semaglutide, Hemoglobin A, General Medicine, ta3121, medicine.disease, Surgery, Cardiovascular diseases, chemistry, Sitagliptin, Administration, Combination, Glycated hemoglobin, business, Type 2, Alogliptin, medicine.drug
Abstract

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to-0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P

Published
2015

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