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Introduction and objectives Metabolic syndrome (MetS) is a combination of various cardiovascular risk factors with a major impact on morbidity and premature mortality. However, the impact of MetS on self-reported health-related quality of life (HRQoL) is unknown. This study evaluated the HRQoL in a Spanish adult population aged 55 years and older with MetS. Method A cross-sectional analysis was performed with baseline data from the PREDIMED-Plus multicentre randomized trial. The participants were 6430 men and women aged 55–75 years with overweight/obesity (body mass index ≥27 and ≤40 kg/m2) and MetS. The SF-36 questionnaire was used as a tool to measure HRQoL. Scores were calculated on each scale of the SF-36 by gender and age. Results Participants showed higher scores in the social function (mean 85.9, 95% CI; 85.4–86.4) and emotional role scales (mean 86.8, 95% CI; 86.0–87.5). By contrast, the worst scores were obtained in the aggregated physical dimensions. In addition, men obtained higher scores than women on all scales. Among men, the worst score was obtained in general health (mean 65.6, 95% CI; 65.0–66.2), and among women, in body pain (mean 54.3, 95%CI; 53.4–55.2). A significant decrease was found in the aggregated physical dimensions score among participants 70–75 years old, but an increased one in the aggregated mental dimensions, compared to younger participants. Conclusions Our results reflect that the MetS may negatively affect HRQoL in the aggregated physical dimensions, body pain in women, and general health in men. However, this adverse association was absent for the psychological dimensions of HRQoL, which were less affected.

Many food items included in the Mediterranean diet (MedDiet) are rich in polyamines, small aliphatic amines with potential cardioprotective effects. The consumption of a MedDiet could increase polyamine concentrations. Based on experimental models, polyamine concentrations may be also influenced by physical activity (PA).We aimed to evaluate whether an intervention based on an energy-restricted MedDiet (er-MedDiet) and PA promotion, in comparison with an energy-unrestricted MedDiet and traditional health care, influences the serum pattern of polyamines and related metabolites in subjects at high risk of cardiovascular disease (CVD).This was a substudy from the PREDIMED-Plus trial, an ongoing randomized clinical trial including 6874 participants allocated either to an intensive weight-loss lifestyle intervention based on er-MedDiet, PA promotion, and behavioral support (er-MedDiet + PA group), or to an energy-unrestricted MedDiet and traditional health care group (MedDiet group). A total of 75 patients (n = 38, er-MedDiet + PA group; n = 37, MedDiet group) were included in this study. Serum concentrations of arginine, ornithine, polyamines, and acetyl polyamines at baseline and 26 wk of intervention were measured by an ultra-high-performance LC-tandem MS platform.At week 26, study groups had similar adherence to the MedDiet but patients randomly assigned to the er-MedDiet + PA group showed significantly lower mean energy intake (-340.3 kcal/d; 95% CI: -567.3, -113.4 kcal/d; P = 0.004), higher mean PA (1290.6; 95% CI: 39.9, 2541.3 metabolic equivalent tasks · min/d; P = 0.043), and higher mean decrease in BMI (in kg/m2) (-1.3; 95% CI: -1.8, -0.6; P 0.001) than the MedDiet group. However, no significant differences in serum polyamines or related metabolites were found between study groups after 26 wk of intervention and no significant between-group differences were found in glycated hemoglobin, HDL-cholesterol, or triglyceride concentrations.In individuals at high CVD risk, an er-MedDiet with increased PA did not result in significant changes of serum concentrations of polyamines or related metabolites in comparison with an energy-unrestricted MedDiet and no increase in PA. This trial was registered at isrctn.com as ISRCTN89898870.

Telerehabilitation interventions administered via a smartphone may provide new feasible and effective rehabilitation options at home for patients with hip fracture. However, to date, no such interventions have been shown to be effective in the recovery key health outcomes of these patients. The present multicentre randomized controlled trial (RCT) aims to test the effect of the ActiveHip+ m-Health system in the recovery of physical performance, functional level, quality of life, and other health-related outcomes in both patients with hip fracture and their family caregivers. A total of 104 patients older than 65 years, with hip fracture, and their family caregivers will be randomized into the ActiveHip+ rehabilitation (N = 52) or the control group (N = 52). ActiveHip+ is a 12-week smartphone-based rehabilitation program conducted in Granada and Cádiz (Spain) that includes: (1) 24 sessions of physical exercise and 12 sessions of occupational therapy; (2) seven educational modules for patients and for caregivers; and (3) general recommendations in activities of daily living. The control group will receive the usual rehabilitation protocol offered by the Andalusian Public Healthcare System. The primary outcome is the patient's physical performance, while the secondary outcomes are the patient's functional level, quality of life, pain, fear of falling, fitness perception, pre-fracture functional level, emotional status, and caregiver burden. The present project will substantially contribute to the existing knowledge by testing for the first time the efficacy and feasibility of a multidisciplinary m-Health system in the rehabilitation of patients with hip fracture.

Proporcionar unas recomendaciones prácticas para el manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia. Participantes: Miembros del Grupo de Metabolismo Mineral de la Sociedad Española de Endocrinología y Nutrición. Métodos Las recomendaciones se formularon de acuerdo con el sistema Grading of Recommendations Assessment, Development, and Evaluation (GRADE) para establecer tanto la fuerza de las recomendaciones como el grado de evidencia. Se realizó una búsqueda sistemática en Medline de la evidencia disponible para cada patología. Se revisaron artículos escritos en inglés con fecha de inclusión hasta 29 de febrero del 2020. Un metodólogo resolvió las diferencias que surgieron durante el proceso de revisión de la bibliografía y formulación de recomendaciones. Tras la formulación de las recomendaciones, estas se discutieron en una reunión conjunta del Grupo de Trabajo. Conclusiones El documento establece unas recomendaciones prácticas basadas en la evidencia acerca del manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia. To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation. Participants: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition. Methods Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodologist resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group. Conclusions The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation. Sin financiación 1.833 JCR (2021) Q4, 135/146 Endocrinology & Metabolism 0.350 SJR (2021) Q3, 168/240 Endocrinology, Diabetes and Metabolism No data IDR 2021 UEM

Objective Metformin modifies the gut microbiome in type 2 diabetes and gastrointestinal tolerance to metformin could be mediated by the gut microbiome. Methods We enrolled 35 patients with type 2 diabetes not receiving treatment with metformin due to suspected gastrointestinal intolerance. Metformin was reintroduced at 425 mg, increasing 425 mg every two weeks until reaching 1700 mg per day. According to the occurrence of metformin-related gastrointestinal symptoms, patients were classified into three groups: early intolerance, non-tolerant, and tolerant. Gut microbiota was profiled with 16 S rRNA. This sequencing aimed to determine the differences in the baseline gut microbiota in all groups and prospectively in the tolerant and non-tolerant groups. Results The classification resulted in 15 early intolerant, 10 tolerant, and 10 non-tolerant subjects. Early tolerance was characterized by a higher abundance of Subdoligranulum; while Veillonella and Serratia were higher in the non-tolerant group. The tolerant group showed enrichment of Megamonas, Megamonas rupellensis, and Phascolarctobacterium spp; Ruminococcus gnavus was lower in the longitudinal analysis. At the end point Prevotellaceae, Prevotella stercorea, Megamonas funiformis, Bacteroides xylanisolvens, and Blautia producta had a higher relative abundance in the tolerant group compared to the non-tolerant group. Subdoligranulum, Ruminococcus torques_1, Phascolarctobacterium faecium, and Eubacterium were higher in the non-tolerant group. The PICRUSt analysis showed a lower activity of the amino acid biosynthesis pathways and a higher sugar degradation pathway in the intolerant groups. Conclusions Gut microbiota of subjects with gastrointestinal intolerance depicted taxonomic and functional differences compared to tolerant patients, and this changed differently after metformin administration

Introduction Controlling postprandial glycemia (PPG) is important to achieve optimal glycemic control, but few studies have evaluated how often is measured and evaluated. Objectives To evaluate how often patients on insulin therapy measure PPG and modify insulin doses accordantly. As secondary objectives, we evaluated the factors conditioning elevated PPG and associated issues. Material and methods Cross-sectional observational study based on a web-based survey from an unselected sample of adult insulin-treated patients. A p-value of Results 1251 patients (68% women, 38.9 ± 13 years [mean ± SD], body mass index (BMI) 24.2 ± 4.2 kg/m2, diabetes duration 17.4 ± 12.8 years, insulin dose 38 ± 18 IU) participated, 1104 with autoinmmune disease (AD) and 147 with non-autoinmmune diabetes (NAD). 59% of patients had HbA1c ≤ 7%, 92.7% of patients with AD and 55.8% with NAD were attended by specialists (p Conclusions Patients with AD determine PPG more frequently. Diabetes type, follow-up setting, number of injections and CGMS use were the most important predictive factors for PPG measurement. Diabetes education programs should address how to best monitor PPG and appropriate corrective actions.

To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation.Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition.Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodologist resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group.The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation.

Background In the last years, evidence that dietary vitamin K could have a role in the cognitive domain has increased. However, data from large trials are limited. The objective of this study was to assess the association of 2 year changes in the dietary intake of vitamin K with cognitive function measured through neuropsychological performance tests. Methods In 5,533 participants of the multicentre PREDIMED-Plus study (48.1% women, age 65.1 ± 4.9 years with overweight/obesity and metabolic syndrome), we assessed the adjusted odds ratios of cognitive function decline according to 2 year changes in vitamin K intake. Participants answered a battery of cognitive function tests and Food Frequency Questionnaires (FFQs) in order to estimate the vitamin K dietary intake. Results After adjusting for potential cofounders, the highest tertile of change of dietary vitamin K intake (median [IQR]; 194.4 μg/d [120.9, 373.1]) was inversely associated with a Mini-Mental State Examination (MMSE) score ≤24 (OR [95% CI]; 0.53 [0.35, 0.79] P for trend = 0.002) compared with a decrease in the intake of vitamin K (median [IQR]; −97.8 μg/d [−292.8, −51.5]). A significant positive association between changes in dietary vitamin K intake and the semantic verbal fluency test scores (OR [95% CI]; 0.69 [0.51, 0.94] P for trend = 0.019) was found. Conclusions An increase of the intake of dietary vitamin K was associated with better cognitive function scores, independently of recognised risk factors for cognitive decline, in an older adult Mediterranean population with high cardiovascular risk.

Osteoporosis is a common chronic disease characterized by a decrease in bone mineral density, impaired bone strength, and an increased risk of fragility fractures. Fragility fractures are associated with significant morbidity, mortality and disability and are a major public health problem worldwide. The influence of nutritional factors on the development and progression of this disease can be significant and is not yet well established. Calcium intake and vitamin D status are considered to be essential for bone metabolism homeostasis. However, some recent studies have questioned the usefulness of calcium and vitamin D supplements in decreasing the risk of fractures. The adequate intake of protein, vegetables and other nutrients is also of interest, and recommendations have been established by expert consensus and clinical practice guidelines. It is important to understand the influence of nutrients not only in isolation but also in the context of a dietary pattern, which is a complex mixture of nutrients. In this review, we evaluate the available scientific evidence for the effects of the main dietary patterns on bone health. Although some dietary patterns seem to have beneficial effects, more studies are needed to fully elucidate the true influence of diet on bone fragility., Instituto de Salud Carlos III PI18/01235, European Union (EU)

[Background]: Overall quality of dietary carbohydrate intake rather than total carbohydrate intake may determine the risk of cardiovascular disease (CVD)., [Objective]: We examined 6- and 12-mo changes in carbohydrate quality index (CQI) and concurrent changes in several CVD risk factors in a multicenter, randomized, primary-prevention trial (PREDIMED-Plus) based on an intensive weight-loss lifestyle intervention program., [Methods]: Prospective analysis of 5373 overweight/obese Spanish adults (aged 55–75 y) with metabolic syndrome (MetS). Dietary intake information obtained from a validated 143-item semiquantitative food-frequency questionnaire was used to calculate 6- and 12-mo changes in CQI (categorized in quintiles), based on 4 criteria (total dietary fiber intake, glycemic index, whole grain/total grain ratio, and solid carbohydrate/total carbohydrate ratio). The outcomes were changes in intermediate markers of CVD., [Results]: During the 12-mo follow-up, the majority of participants improved their CQI by increasing their consumption of fruits, vegetables, legumes, fish, and nuts and decreasing their consumption of refined cereals, added sugars, and sugar-sweetened beverages. After 6 mo, body weight, waist circumference (WC), systolic and diastolic blood pressure (BP), fasting blood glucose, glycated hemoglobin (HbA1c), triglyceride levels, triglycerides and glucose (TyG) index, and TyG-WC decreased across successive quintiles of improvement in the CQI. After 12 mo, improvements were additionally observed for HDL cholesterol and for the ratio of total to HDL cholesterol. Favorable improvements (expressed in common units of SD and 95% CI) for quintile 5 compared with quintile 1 of CQI change were observed for most risk factors, including TyG-WC (SD −0.20; 95% CI −0.26, −0.15), HbA1c (SD −0.16; 95% CI −0.23, −0.10), weight (SD −0.12; 95% CI −0.14, −0.09), systolic BP (SD −0.11; 95% CI −0.19, −0.02) and diastolic BP (SD −0.11; 95% CI −0.19, −0.04)., [Conclusions]: Improvements in CQI were strongly associated with concurrent favorable CVD risk factor changes maintained over time in overweight/obese adults with MetS. This trial was registered as ISRCTN 89898870., The PREDIMED-Plus trial was supported by the European Research Council (advanced research grant 2013–2018, 340918 to MAM-G as PI) and by the official Spanish Institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn) and Instituto de Salud Carlos III (ISCIII), through the Fondo de Investigación en Salud (FIS), which is cofunded by the European Regional Development Fund (4 coordinated FIS projects), the Especial Action Project entitled Implementación y evaluación de una intervención intensiva sobre la actividad física Cohorte PREDIMED-Plus grant, the Recercaixa grant (2013ACUP00194), grants from the Consejería de Salud de la Junta de Andalucía, a grant from the Generalitat Valenciana, a SEMERGEN grant, and funds from the European Regional Development Fund (CB06/03)

Recently, a number of studies have related the development of highly prevalent disorders such as type 2 diabetes and obesity to gut microbiota. Obesity itself have been associated with modifications in gut microbiota composition, and a tendency towards an overgrowth of microorganisms that obtain more efficient energy from diet. It's capacity to decompose the polysaccharides that can not be digested by the host, increase monosaccharide and short chain fatty acid (SCFA) production. However, the increase in fat mass is not only due to a more efficient harvest of energy, but also the microbiota participates in changes in endotoxemia, bowel permeability, insulin resistance, hormonal environment, expression of genes regulating lipogenesis, interaction with bile acids, as well as changes in the proportion of brown adipose tissue, and effects associated with the use of drugs such as metformin. Currently, use of prebiotics and probiotics and other innovative techniques like antibiotic therapy or gut microbiota transplant, has been proposed as suitable tools to control the development of metabolic diseases such as obesity or insulin resistance through the diet.

Glucagon-like peptide-1 (GLP-1) receptor analogs are a group of therapeutic agents which mimic endogenous GLP-1, exerting their effect by the stimulation of the GLP-1 receptor with a wide distribution. Its activation increases insulin releasing dependent on blood glucose levels, suppression of glucagon secretion and a reduction of hepatic glucose output. It delays gastric emptying and increases satiety. Exenatide is the synthetic version of exendin-4, a natural peptide with similar properties to human GLP-1. There are two pharmaceutical forms, for subcutaneous injection: twice daily and once weekly. Clinical practice guidelines recommend them because of a high efficacy reducing hyperglycemia, low risk of hypoglycemia and a significative weight loss effect. Gastrointestinal adverse events are the most common beside injection site-related. Their cost is the main limitation to use. Areas covered: We review the recent literature investigating the pharmacokinetics and pharmacodynamics and efficacy-safety studies of exenatide twice daily and once weekly in type 2 diabetes Expert opinion: GLP-1 receptor analogs are now positioned as an effective and safe drug for the treatment of type 2 diabetes. Exenatide significally reduces HbA1c and fasting plasma glucose. Additionally, it produces moderate weight loss and decreases blood pressure. One weekly formulation may improve compliance while cost is still a limitation. EXSCEL trial has shown that, despite cardiovascular safety, exenatide do not exhibits cardiovascular benefits.

Objective: The hypertriglyceridemic waist (HTGW) phenotype is characterized by abdominal obesity and high levels of triglycerides. In a cross-sectional assessment of PREDIMED-Plus trial participants at baseline, HTGW phenotype prevalence was evaluated, associated risk factors were analyzed, and the lifestyle of individuals with metabolic syndrome and HTGW was examined. Methods: A total of 6,874 individuals aged 55 to 75 with BMI ≥ 27 and < 40 kg/m2 were included and classified by presence (HTGW+ ) or absence (HTGW- ) of HTGW (waist circumference: men ≥ 102 cm, women ≥ 88 cm; fasting plasma triglycerides ≥ 150 mg/dL). Analytical parameters and lifestyle (energy intake and expenditure) were analyzed. Results: A total of 38.2% of the sample met HTGW+ criteria. HTGW+ individuals tended to be younger, have a greater degree of obesity, be sedentary, and be tobacco users. They had higher peripheral glucose, total cholesterol, and low-density lipoprotein cholesterol levels; had lower high-density lipoprotein cholesterol levels; and had increased prevalence of type 2 diabetes mellitus. Mediterranean diet (MedDiet) adherence and physical activity were greater in HTGW- patients. Age, BMI, tobacco use, total energy expenditure, hypertension, type 2 diabetes mellitus, and MedDiet adherence were associated with HTGW+ . Conclusions: HTGW is a highly prevalent phenotype in this population associated with younger age, higher BMI, tobacco use, and decreased MedDiet adherence. HTGW- individuals were more physically active with greater total physical activity, and fewer had hypertension. The PREDIMED-Plus trial was supported by grants from the Instituto de Salud Carlos III, cofinanced by the Fondo Europeo de Desarrollo Regional-FEDER including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, and PI17/00926; the Cohorte PREDIMED-PLUS grant; the European Research Council (Advanced Research Grant 2014–2019, 340918 granted to MAM-G); the Recercaixa grant (2013ACUP00194); grants from Consejeria de Salud de la Junta de Andalucia (PI0458/2013, PS0358/2016, PI0092/2017, PI0096/2017 and PI0137/2018); a grant from the Generalitat Valenciana (PROMETEO/2017/017); a SEMERGEN grant, and funds from the European Regional Development Fund (CB06/03).

Background and Aims: “T-Coach® program” is a telephone support platform for type 2 diabetes (T2D) on glargine U300 insulin. This study aimed to evaluate whether this program was effective in helping patients reach their optimal insulin dose. Materials and Methods: Both T2D patients who were initiating glargine U300 or requiring dose titration, enrolled in T-Coach® program, were included in the study. Telephone intervention was delivered by diabetes nurse educators and consisted of regular telephone sessions, aimed at achievement of target fasting blood glucose (FBG) and reinforce diabetes education. The optimal insulin dose (OID) was defined as the dose of Glargine U300 required to achieve target FBG. The primary outcome was whether a patient reached the OID dose within 6 months. Results: A total of 589 patients consented and were included in TCoach program®. Median age was 65.4±11.2 years; 51.8% men; BMI 30.3±6 kg/m2. Of them, 65.9% were already on basal insulin (17.7% on Glargine U300). Mean glargine U300 dose was 27.4±15.9 UI. Mean baseline HbA1c was 9.4±1.8%, and basal FBG was 215.2±66.2 mg/dL. Mean FBG target was 88.7-132.3 mg/dl. Of them, 77.6% reached their OID at 6 months (75.7% at 3 months, and 41.2% at 1 month), and they did so in an average of 2.2±1.8 months. Mean FBG levels fell from 215.2 mg/dL to 137.9 mg/dL, 117.9 mg/dL and 115.9 mg/dL at months 1,3 and 6, respectively. Mean glargine U300 dose increased from 27.4 UI to 30.4 UI at month 6. Knowledge and adherence questionnaires were given to the patients. Mean score in knowledge questionnaire increased from 4.8 to 7.6 after the program. Moreover, a satisfaction survey was completed by 208 patients. The program was very well graded, with an average score of 9.1 out of 10. Conclusion: The T-Coach® program is an effective way to help patients reach their optimal insulin glargine U300 dose, improves glycemic control and can be an effective support for diabetes education. Disclosure D. Bellido Guerrero: None. V. Bellido: None. C. Morales: Other Relationship; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. J. García: None. A. Muñoz-Garach: Speaker's Bureau; Self; Lilly Diabetes, Novo Nordisk A/S, Sanofi-Aventis. J.L. Fernandez Morera: None. B. Gonzalez Aguilera: None. M. López de la Torre: None. P. Fuentealba: Employee; Self; Sanofi.

Introduction: Controlling postprandial glycemia (PPG) is critical to achieve glycemic targets and has been associated with poor cardiovascular outcomes. However, few patients measure PPG and even less make changes on treatment based on these data. Objectives: To evaluate how often patients on insulin therapy analyze PPG and modify insulin doses based on these data. As secondary objectives, we evaluate how patients discussed PPG during the visits and the predictive factors for PPG measurement. Material and Methods: This was an anonymous on-line cross-sectional observational study of an unselected sample of diabetes patients on insulin. Data were extracted from a questionnaire available in two internet sources: Canal Diabetes and the Spanish Diabetes Foundation. The study was approved by the Ethics Committee of the Fundación Jiménez Díaz Hospital in Madrid. Results: Data presented as means ± (SD) or frequencies (%). Among the predictive factors for PPG measurement and based treatment changes were diabetes type, follow-up setting (Specialized vs. Primary Care), insulin injection number and CGM use. Conclusions: In this unselected on-line sample of insulin-treated adults, 50.7% measured their PPG, despite this was recommended by HCP and most (95%) considered PPG measurement as relevant. Therefore, improvement in diabetes education on PPG and its treatment is key to improve overall glycemic control. Disclosure C. Tejera: None. E. Lecumberri: None. A. Muñoz-Garach: Speaker's Bureau; Self; Lilly Diabetes, Novo Nordisk A/S, Sanofi-Aventis. F. Ampudia Blasco: None. F. Ampudia Blasco: None.

To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes.PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbAAt month 6, the mean change in HbAThe use of telemedicine in patients with type 1 diabetes with HbA

Changes in the intestinal microbial community and some metabolic disturbances, including obesity and type2 diabetes, are related. Glucagon-like peptide-1 (GLP-1) regulates glucose homeostasis. Microbiota have been linked to incretin secretion. Antibiotic use causes changes in microbial diversity and composition. Our aim was to evaluate the relationship between microbiota changes and GLP-1 secretion. A prospective case-control study with a Helicobacter pylori-positive patient model involving subjects under eradication therapy (omeprazole, clarithromycin, and amoxicillin). Forty patients with H. pylori infection and 20 matched participants, but negative for H. pylori antigen. Patients were evaluated before and two months after treatment. We analyzed anthropometric measurements, carbohydrate metabolism, lipid profile, and C-reactive protein. Gut microbiota composition was analyzed through 16S rRNA amplicon sequencing (IlluminaMiSeq). Eradication treatment for H. pylori decreased bacterial richness (Chao1, p = 0.041). Changes in gut microbiota profiles were observed at phylum, family, genus and species levels. GLP-1 secretion and variables of carbohydrate metabolism were improved. Correlations were seen between GLP-1 changes and variations within microbial community abundances, specifically Bifidobacterium adolescentis, the Lachnobacterium genus, and Coriobacteriaceae family. A conventional treatment to eradicate H. pylori could improve carbohydrate metabolism possibly in relation with an increase in GLP-1 secretion. GLP-1 secretion may be related to alterations in intestinal microbiota, specifically Lachnobacterium, B. adolescentis and Coriobacteriaceae.

BackgroundH. pylori infection and eradication cause perturbations of the gut microbiome. The gut microbiota has been identified as a potential contributor to metabolic diseases. We evaluate whether these alterations in intestinal microbiota composition produced by H. pylori infection and its posterior eradication with antibiotic treatment could be associated with glucose homeostasis in metabolically healthy subjects.MethodsForty adult patients infected with H. pylori and 20 control subjects were recruited. The infected subjects were evaluated before and two months after eradication treatment (omeprazole, clarithromycin, amoxicillin). The microbiota composition in fecal samples was determined by 16S rRNA gene (V3-V4) sequencing using Illumina Miseq.ResultsPatients (pre- and post-H. pylori eradication) showed a decreased bacterial richness and diversity with respect to controls. There was an improvement in glucose homeostasis in subjects two months after H. pylori eradication treatment. Changes in the amount of Rikenellaceae, Butyricimonas, E. biforme, B. fragilis, and Megamonas were inversely associated with changes in the glucose level or related parameters (Hb1ac) in H. pylori eradication subjects.ConclusionsH. pylori infection and eradication with antibiotic treatment causes alteration of the human gut microbiome. The increase in SCFA-producing bacteria and glucose-removing bacteria, specifically members of Megamonas, Rikenellaceae and Butyricimonas, has been related with an improvement in glucose homeostasis after H. pylori eradication with antibiotic treatment.

The authors especially thank the PREDIMED-Plus participants for their enthusiastic collaboration, the PREDIMED-Plus personnel for their outstanding support, and the personnel of all associated primary care centers for their exceptional effort. Centros de Investigación Biomédica en Red: Obesidad y Nutrición (CIBEROBN), Centros de Investigación Biomédica en Red: Epidemiología y Salud Pública (CIBERESP) and Centros de Investigación Biomédica en Red: Diabetes y Enfermedades Metabólicas asociadas (CIBERDEM) are initiatives of Instituto de Salud Carlos III (ISCIII), Madrid, Spain. We thank the PREDIMED-Plus Biobank Network, part of the National Biobank Platform of ISCIII for storing and managing biological samples. Food companies, Hojiblanca and Patrimonio Comunal Olivarero, donated extra-virgin olive oil and Almond Board of California, American Pistachio Growers and Paramount Farms donated nuts., The PREDIMED-Plus trial was supported by the official funding agency for biomedical research of the Spanish government, ISCIII through the Fondo de Investigación para la Salud (FIS), which is co-funded by the European Regional Development Fund (four coordinated FIS projects led by Jordi Salas-Salvadó and Josep Vidal, including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, PI17/00926, the Especial Action Project entitled: Implementación y evaluación de una intervención intensives obre la actividad física Cohorte PREDIMED-PLUS grant to Jordi Salas-Salvadó, the European Research Council (Advanced Research Grant 2013-2018; 340918) grant to Miguel Ángel Martínez-Gonzalez, the Recercaixa grant to Jordi Salas-Salvadó (2013ACUP00194), the grant from the Consejería de Salud de la Junta de Andalucía (PI0458/2013; PS0358/2016), grants from the Consejería de Salud de la Junta de Andalucía (PI0458/2013; PS0358/2016; PI0137/2018), the PROMETEO/2017/017 grant from the Generalitat Valenciana, the SEMERGEN grant and FEDER funds (CB06/03), Olga Castaner is granted by the JR17/00022, ISCIII. Christopher Papandreou is supported by a postdoctoral fellowship granted by the Autonomous Government of Catalonia (PERIS 2016-2020 Incorporació de Científics I Tecnòlegs, SLT002/0016/00428). Jadwiga Konieczna is supported by the "FOLIUM" program within the FUTURMed project. Talent for the medicine within the future from the Fundació Institut d’Investigació Sanitària Illes Balears. This call is co-financed at 50% with charge to the Operational Program FSE 2014-2020 of the Balearic Islands. José C. Fernández-García is supported by a research contract from Servicio Andaluz de Salud (SAS) (B-0003-2017). None of the funding sources took part in the design, collection, analysis or interpretation of the data, or in the decision to submit the manuscript for publication. The corresponding authors had full access to all the data in the study and had final responsibility to submit for publication., The datasets generated and analysed during the current study are not publicly available due to national data regulations and for ethical reasons, including the possibility that some information might compromise research participants’ consent because our participants only gave their consent for the use of their data by the original team of investigators. However, these data can be requested by signing a data sharing agreement as approved by the relevant research ethics committees and the steering committee of the PREDIMED-Plus study., Research examining associations between objectively-measured napping time and type 2 diabetes (T2D) is lacking. This study aimed to evaluate daytime napping in relation to T2D and adiposity measures in elderly individuals from the Mediterranean region. A cross-sectional analysis of baseline data from 2190 elderly participants with overweight/obesity and metabolic syndrome, in the PREDIMED-Plus trial, was carried out. Accelerometer-derived napping was measured. Prevalence ratios (PR) and 95% confidence intervals (CI) for T2D were obtained using multivariable-adjusted Cox regression with constant time. Linear regression models were fitted to examine associations of napping with body mass index (BMI) and waist circumference (WC). Participants napping ≥90 min had a higher prevalence of T2D (PR 1.37 (1.06, 1.78)) compared with those napping 5 to, Fondo de Investigación para la Salud (FIS), which is co-funded by the European Regional Development Fund (four coordinated FIS projects led by Jordi Salas-Salvadó and Josep Vidal, including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, PI17/00926, Especial Action Project entitled: Implementación y evaluación de una intervención intensives obre la actividad física Cohorte PREDIMED-PLUS grant to Jordi Salas-Salvadó, the European Research Council (Advanced Research Grant 2013-2018; 340918), Grant to Jordi Salas-Salvadó (2013ACUP00194), the grant from the Consejería de Salud de la Junta de Andalucía (PI0458/2013; PS0358/2016), grants from the Consejería de Salud de la Junta de Andalucía (PI0458/2013; PS0358/2016; PI0137/2018), the PROMETEO/2017/017 grant from the Generalitat Valenciana, the SEMERGEN grant and FEDER funds (CB06/03), Olga Castaner is granted by the JR17/00022, ISCIII, Autonomous Government of Catalonia (PERIS 2016-2020 Incorporació de Científics I Tecnòlegs, SLT002/0016/00428)

Scope: To examine the association between milk and dairy products intake and the prevalence of cognitive decline among Spanish individuals at high cardiovascular risk. Methods and results: Cross-sectional analyses are performed on baseline data from 6744 adults (aged 55-75 years old). Intake of milk and dairy products is estimated using a food frequency questionnaire grouped into quartiles. The risk of developing cognitive impairment is based on the Mini-Mental State Examination (MMSE). A higher prevalence of cognitive decline was found in subjects who consumed more grams. Patients with worse MMSE score (10-24) consumed a mean of 395.14 ± 12.21 g, while patients with better MMSE score (27-30) consumed a mean of 341.23 ± 2.73 g (p < 0.05). Those subjects with the lower milk consumption (

Resumen En los ultimos anos son muy numerosos los trabajos que han relacionado la microbiota intestinal con el desarrollo de enfermedades de alta prevalencia como son la diabetes tipo 2 y la obesidad. La obesidad por si misma se asocia con cambios en la composicion de la microbiota intestinal con tendencia al sobrecrecimiento de microorganismos con una mayor eficiencia en la obtencion de la energia de la dieta. Son varios los mecanismos que relacionan la microbiota con la aparicion de insulinorresistencia y diabetes, entre ellos destacan los cambios en la permeabilidad intestinal, endotoxemia, interrelacion con acidos biliares, cambios en la proporcion de tejido adiposo marron y efectos asociados al uso de farmacos como la metformina. Actualmente, a traves de la dieta, el uso de pro y prebioticos y otras nuevas tecnicas como el trasplante de microbiota intestinal, o incluso la terapia con antibioticos, se postulan como herramientas utiles para modular la aparicion de obesidad e insulinorresistencia.

Introduction Lack of control in diabetic patients has stimulated the development of new insulin analogues. One of these was basal insulin peglispro (BIL) or LY2605541; it had a large hydrodynamic size, flat pharmacokinetic profile, half life of 2–3 days and acted preferably in the liver. Methods We reviewed the recent literature examining the pharmacokinetics, pharmacodynamics, efficacy and safety of BIL treatment in type 2 diabetes patients. Results The pharmacodynamic and pharmacokinetic outline of BIL seemed to have an advantage over neutral protamine Hagedorn and glargine insulins. Recently, phase 3 studies suggested BIL was superior to glargine in reducing glucose levels in type 1 and type 2 diabetes patients in addition to causing less weight gain. It showed a different hypoglycaemia rate profile depending on the study population, with less nocturnal hypoglycaemia compared to glargine. Unfortunately, it caused higher transaminase and triglyceride levels, which led the company to discontinue development. The decision came after it had been analysed by the regulatory authorities and other external experts concerning the worse liver profile data from the IMAGINE trials. Conclusions BIL was an adequate basal insulin analogue with interesting specific properties. Unfortunately the disadvantages as shown in the lipid values and liver function tests led to its failure.

Environmental temperature has been described to affect plasma glucose levels after oral glucose tolerance testing (OGTT).We evaluated the relationship between seasons and environmental temperature and gestational diabetes mellitus (GDM) diagnosis and treatment.We analyzed data from 2374 women retrospectively. GDM was diagnosed in 473 patients by a 100-g OGTT. OGTT results and needing of insulin therapy were evaluated in relation to seasons and environmental temperature (mean temperature and temperature change) the day of the OGTT and the preceding 14 and 28 days.We found significant seasonal differences in the percentage of GDM: 24.4% in summer vs. 15.6% in autumn (p 0.01). The odds ratio (OR) for being diagnosed with GDM was 1.78 in summer relative to autumn, after controlling for age. A higher mean temperature the day of the OGTT and the preceding 14 and 28 days increased the risk of being diagnosed with GDM the months in which temperature was rising (March-August) but not the months in which temperature was decreasing (September-February). We observed a negative correlation between temperature and fasting glucose and a positive correlation with post-load glucose. Neither the season nor the environmental temperature affected the risk of requiring insulin therapy.There is a higher prevalence of GDM diagnosis at warmer seasons and at rising temperatures the 2-4 weeks prior to the OGTT. The impact of temperature is different between fasting and post-load glucose.

Objective: Polyamines are naturally occurring cationic molecules present in all living cells. Dysregulation of circulating polyamines has been reported in several conditions, but little is known about the levels of serum polyamines in chronic metabolic disorders such as type 2 diabetes (T2D). Therefore, the aim of this study was to evaluate the polyamine-related metabolome in a cohort of metabolic syndrome individuals with and without T2D. Design and methods: This was a nested case–control study within the PREDIMED-Plus trial that included 44 patients with T2D and 70 patients without T2D. We measured serum levels of arginine, ornithine, polyamines, and acetyl polyamines with an ultra-high performance liquid chromatography tandem mass spectrometry platform. Results: Our results showed that serum putrescine, directly generated from ornithine by the catalytic action of the biosynthetic enzyme ornithine decarboxylase, was significantly elevated in patients with T2D compared to those without T2D, and that it significantly correlated with the levels of glycosylated hemoglobin (HbA1c). Correlation analysis revealed a significantly positive association between fasting insulin levels and spermine. Multiple logistic regression analysis (adjusted for age, gender and body weight index) revealed that serum putrescine and spermine levels were associated with a higher risk of T2D. Conclusions: Our study suggests that polyamine metabolism is dysregulated in T2D, and that serum levels of putrescine and spermine are associated with glycemic control and circulating insulin levels, respectively.

Type 2 diabetes (T2D), a multifactorial and chronic disease, requires in an elevated percentage of patients the association of several antidiabetic drugs to achieve optimal glycemic control. Dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter inhibitors (SGLT2i) are new classes of oral antidiabetic drugs developed over the last years.This paper summarizes the safety of DPP-4i and SGLT2i combination therapies. Relevant studies were identified through searches in PubMed.DPP4i and SGLT2i are antidiabetic drugs that lower blood glucose without causing hypoglycaemia or weight increase. More importantly, cardiovascular trials have clearly demonstrated the cardiovascular safety of DPP4i and a reduction in cardiovascular events with SGLT2i (empagliflozin and canagliflozin). Therefore, the association of both therapeutic groups could be an attractive option to achieve optimal blood glucose control in T2D because of their complementary mechanism of action. Clinical trials evaluating the combination of SGLT2i and DPP4i show that the co-administration of these drugs in fixed-dose combinations in comparison to separate tablets does not carry additional safety concerns that each individual drug, but increases therapeutic effects. Therefore, this antidiabetic combination is a safe and effective therapy for patients with T2D.

Malnutrition in hospitalized patients is associated with an increased risk of death, in both the short and the long term.The purpose of this study was to determine which nutrition-related risk index predicts long-term mortality better (three years) in patients who receive total parenteral nutrition (TPN).This prospective, multicenter study involved noncritically ill patients who were prescribed TPN during hospitalization. Data were collected on Subjective Global Assessment (SGA), Nutritional Risk Index (NRI), Geriatric Nutritional Risk Index (GNRI), body mass index, albumin and prealbumin, as well as long-term mortality.Over the 1- and 3-year follow-up periods, 174 and 244 study subjects (28.8% and 40.3%) respectively, died. Based on the Cox proportional hazards survival model, the nutrition-related risk indexes most strongly associated with mortality were SGA and albumin (2.5 g/dL) (after adjustment for age, gender, C-reactive protein levels, prior comorbidity, mean capillary blood glucose during TPN infusion, diabetes status prior to TPN, diagnosis, and infectious complications during hospitalization).The SGA and very low albumin levels are simple tools that predict the risk of long-term mortality better than other tools in noncritically ill patients who receive TPN during hospitalization.

The relationship between 25-hydroxyvitamin D [25(OH)D] and obesity and type 2 diabetes is not completely understood. Vitamin D receptor (VDR) expression in adipose tissue (AT) is related to obesity and might be regulated by 1,25-dihydroxyvitamin D3 [1,25(OH)2D3].To analyze serum 25(OH)D and VDR gene expression in AT according to body mass index (BMI) and glycemic status and the effect of 1,25(OH)2D3 on AT according to BMI.Two cohorts were studied: 1) 118 subjects classified according to their BMI (lean, overweight, obese, or morbidly obese [MO]) and their glycemic status (normoglycemic [NG] and prediabetic and diabetic [PD]); and 2) 30 obese subjects (BMI30 kg/m(2)) classified as NG and PD. VDR gene expression was analyzed during preadipocyte differentiation and in vitro stimulation with 1,25(OH)2D3 of AT explants from donors with different BMI values.University Hospital.Serum 25(OH)D, parathyroid hormone (PTH), and AT VDR gene expression.25(OH)D levels were lower in PD than NG subjects, significantly so in the lean and MO groups (P.05). 25(OH)D levels correlated negatively with homeostasis model of assessment for insulin resistance (HOMA-IR) (r = -0.200; P = .032) and glucose (r = -0.295; P = .001), but not with BMI. VDR gene expression was higher in MO than in the other BMI groups (P.05). 1,25(OH)2D3 increased VDR gene expression in AT from obese patients (P.05) but not from lean subjects.25(OH)D levels are diminished in PD compared to NG subjects, independently of BMI, and are closely related to glucose metabolism variables, suggesting that vitamin D deficiency is associated more with carbohydrate metabolism than with obesity. Moreover, AT has a different response to 1,25(OH)2D3 depending on the degree of obesity.

Objective Hypoglycemia is a common problem among hospitalized patients. Treatment of hyperglycemia with insulin is potentially associated with an increased risk for hypoglycemia. The aim of this study was to determine the prevalence and predictors of hypoglycemia (capillary blood glucose Methods This prospective multicenter study involved 19 Spanish hospitals. Noncritically ill adults who were prescribed TPN were included, thus enabling us to collect data on capillary blood glucose and insulin dosage. Results The study included 605 patients of whom 6.8% (n = 41) had at least one capillary blood glucose Conclusions The occurrence of hypoglycemia in noncritically ill patients receiving PN is low. A lower BMI and a greater blood glucose variability and TPN duration are factors associated with the risk for hypoglycemia. IV insulin and glucose variability were predictors of symptomatic hypoglycemia.

La diabetes mellitus, enfermedad cronica caracterizada por hiperglucemia, se ha convertido en uno de los mayores problemas de salud publica del siglo XXI. Su prevalencia alcanza cifras alarmantes, afectando a cerca de 382 millones de personas alrededor del mundo. Las perspectivas futuras, ademas, son realmente desalentadoras, ya que se estima que para el ano 2035 el numero de personas con diabetes mellitus aumentara hasta los 592 millones. La diabetes mellitus tipo 2 (DM2) aglutina el 90-95% de los diagnosticos de diabetes mellitus. La hiperglucemia cronica de la DM2, incluso en ausencia de sintomas, conlleva lesiones en multiples tejidos, siendo especialmente sensibles los pequenos vasos de la retina, los rinones y los nervios perifericos. En practicamente todas las sociedades desarrolladas, la

Objective The prevalence of carbohydrate metabolism disorders in patients who receive total parenteral nutrition (TPN) is not well known. These disorders can affect the treatment, metabolic control, and prognosis of affected patients. The aims of this study were to determine the prevalence in noncritically ill patients on TPN of diabetes, prediabetes, and stress hyperglycemia; the factors affecting hyperglycemia during TPN; and the insulin therapy provided and the metabolic control achieved. Methods We undertook a prospective multicenter study involving 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included, and data were collected on demographic, clinical, and laboratory variables (glycated hemoglobin, C-reactive protein [CRP], capillary blood glucose) as well as insulin treatment. Results The study included 605 patients. Before initiation of TPN, the prevalence of known diabetes was 17.4%, unknown diabetes 4.3%, stress hyperglycemia 7.1%, and prediabetes 27.8%. During TPN therapy, 50.9% of patients had at least one capillary blood glucose of > 180 mg/dL. Predisposing factors were age, levels of CRP and glycated hemoglobin, the presence of diabetes, infectious complications, the number of grams of carbohydrates infused, and the administration of glucose-elevating drugs. Most (71.6%) patients were treated with insulin. The mean capillary blood glucose levels during TPN were: known diabetes (178.6 ± 46.5 mg/dL), unknown diabetes (173.9 ± 51.9), prediabetes (136.0 ± 25.4), stress hyperglycemia (146.0 ± 29.3), and normal (123.2 ± 19.9) (P Conclusion The prevalence of carbohydrate metabolism disorders is very high in noncritically ill patients on TPN. These disorders affect insulin treatment and the degree of metabolic control achieved. (Endocr Pract. 2015;21:59-67)