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1. Hyperinsulinism-hyperammonemia syndrome in an infant with seizures

Author

Strajnar A, Tansek MZ, Podkrajsek KT, Battelino T, and Groselj U

Subjects
diazoxide, glud1 gene, glutamate dehy-drogenase, hyperinsulinism-hyperammonemia (hi/ha) syndrome, persistent hyperinsulinemic hypoglycemia of infancy, Genetics, QH426-470
Abstract

Hyperinsulinism-hyperammonemia syndrome (HI/HA) is the second most common form of persistent hyperinsulinemic hypoglycemia of infancy (PHHI). The main clinical characteristics of HI/HA syndrome are repeated episodes of symptomatic hypoglycemia, but not usually severe. Consequently, children with HI/HA syndrome are frequently not recognized in the first months of life. An 8-month-old boy was admitted to a hospital due to hypoglycemia seizures. He also had asymptomatic hyperammonemia with no signs of lethargy or headaches. Genetic testing revealed autosomal dominant syndrome, a mutation in the GLUD1 gene (p.Arg274Cys). The boy started treatment with diazoxide. Subsequent growth and neurological development were normal. Hypoglycemic symptoms in HI/HA syndrome may vary from being non specific to severe. As hypoglycemia could lead to brain injury and impairment of neurological development, timely diagnosis and management are essential. If transient hypoglycemia is ruled out, metabolic disorders must be taken into account.

Published
2018
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6. List of Contributors

Author

Abrahams, Mariette, primary, Alam, Fakhrul, additional, Battelino, T., additional, Boland, Mike, additional, Braconi, Daniela, additional, Bronlund, John, additional, Bryant, Eleanor, additional, Chen, Chih-Han, additional, Cicaloni, Vittoria, additional, De Miguel-Etayo, P., additional, Fehér, András, additional, Gibney, Eileen R., additional, González-Rodríguez, Liliana Guadalupe, additional, Grimaldi, Keith Anthony, additional, Harding, Alice, additional, Iglesia, I., additional, Kamande, Eva W., additional, Katsarou, Vaia, additional, Kimani-Murage, Elizabeth Wambui, additional, Kiss, Marietta, additional, Macharia, Teresia, additional, Moreno, L.A., additional, Muriuki, Peter G., additional, Mutisya, Maurice, additional, Mutoni, Sandrine, additional, Mwaniki, Elizabeth, additional, Nyamasege, Carolyn K., additional, Oliveira, Bruno M.P.M., additional, Ong, Andy S.J., additional, Peral Suárez, África, additional, Perea-Sánchez, José Miguel, additional, Poínhos, Rui, additional, Rankin, Audrey, additional, Robinson, Sarita, additional, Santucci, Annalisa, additional, Singhrao, Sim K., additional, Spiga, Ottavia, additional, Stewart-Knox, Barbara, additional, Szakály, Zoltán, additional, Toumazou, Christofer, additional, Tsolaki, Magdalini, additional, Veiga-Herreros, Pablo, additional, Wainaina, Caroline, additional, Wanjohi, Milka, additional, Wekesah, Frederick Murunga, additional, and Zerfu, Taddese Alemu, additional

Published
2019
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15. INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Author

Dunger, David B., Bruggraber, Sylvaine F. A., Mander, Adrian P., Marcovecchio, M. Loredana, Tree, Timothy, Chmura, Piotr Jaroslaw, Knip, Mikael, Schulte, Anke M., Mathieu, Chantal, Mathieu, C., Gillard, P., Casteels, K., Overbergh, L., Dunger, D., Wallace, C., Evans, M., Thankamony, A., Hendriks, E., Bruggraber, S., Peakman, M., Tree, T., Morgan, N., Richardson, S., Todd, J., Wicker, L., Mander, A., Dayan, C., Alhadj Ali, M., Pieber, T., Eizirik, D., Cnop, M., Brunak, S., Pociot, F., Johannesen, J., Rossing, P., Legido Quigley, C., Mallone, R., Scharfmann, R., Boitard, C., Knip, M., Otonkoski, T., Veijola, R., Lahesmaa, R., Oresic, M., Toppari, J., Danne, T., Ziegler, A. G., Achenbach, P., Rodriguez-Calvo, T., Solimena, M., Bonifacio, E., Speier, S., Holl, R., Dotta, F., Chiarelli, F., Marchetti, P., Bosi, E., Cianfarani, S., Ciampalini, P., de Beaufort, C., Dahl-Jørgensen, K., Skrivarhaug, T., Joner, G., Krogvold, L., Jarosz-Chobot, P., Battelino, T., Thorens, B., Gotthardt, M., Roep, B., Nikolic, T., Zaldumbide, A., Lernmark, A., Lundgren, M., Costecalde, G., Strube, T., Schulte, A., Nitsche, A., von Herrath, M., Wesley, J., Napolitano-Rosen, A., Thomas, M., Schloot, N., Goldfine, A., Waldron-Lynch, F., Kompa, J., Vedala, A., Hartmann, N., Nicolas, G., van Rampelbergh, J., Bovy, N., Dutta, S., Soderberg, J., Ahmed, S., Martin, F., Agiostratidou, G., Koralova, A., Willemsen, R., Smith, A., Anand, B., Puthi, V., Zac-Varghese, S., Datta, V., Dias, R., Sundaram, P., Vaidya, B., Patterson, C., Owen, K., Piel, B., Heller, S., Randell, T., Gazis, T., Bismuth Reismen, E., Carel, J-C, Riveline, J-P, Gautier, J-F, Andreelli, F., Travert, F., Cosson, E., Penfornis, A., Petit, C., Feve, B., Lucidarme, N., Beressi, J-P, Ajzenman, C., Radu, A., Greteau-Hamoumou, S., Bibal, C., Meissner, T., Heidtmann, B., Toni, S., Rami-Merhar, B., Eeckhout, B., Peene, B., Vantongerloo, N., Maes, T., Gommers, L., Marcovecchio, M.L., Vela, J., Latres, E., Children's Hospital, and HUS Children and Adolescents

Subjects
Trials, Adult, Adolescent, SARS-CoV-2, Prevention, Beta-cell function, COVID-19, Medicine (miscellaneous), Beta-cell Function, C-peptide, Master Protocol, Phase 2, Type 1 Diabetes, Type 1 diabetes, Diabetes Mellitus, Type 1, Treatment Outcome, 3121 General medicine, internal medicine and other clinical medicine, Diabetes Mellitus, Type 1/diagnosis, Master protocol, Humans, Pharmacology (medical), Child, Biomarkers
Abstract

Background The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials. Methods In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow. Discussion The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers.

Published
2022

16. Prenatal dexamethasone treatment for classic 21-hydroxylase deficiency in Europe

Author

Nowotny, H., Neumann, U., Tardy-Guidollet, V., Ahmed, S.F., Baronio, F., Battelino, T., Bertherat, J., Blankenstein, O., Bonomi, M., Bouvattier, C., Perrière, A. Brac de la, Brucker, S., Cappa, M., Chanson, P., Claahsen-van der Grinten, H.L., Colao, A., Cools, M., Davies, J.H., Dörr, H.G., Fenske, W.K., Ghigo, E., Giordano, R., Gravholt, C.H., Huebner, A., Husebye, E.S., Igbokwe, R., Juul, A., Kiefer, F.W., Léger, J., Menassa, R., Meyer, G., Neocleous, V., Phylactou, L.A., Rohayem, J., Russo, G., Scaroni, C., Touraine, P., Unger, N., Vojtková, J., Yeste, D., Lajic, S., Reisch, N., Nowotny, H., Neumann, U., Tardy-Guidollet, V., Ahmed, S.F., Baronio, F., Battelino, T., Bertherat, J., Blankenstein, O., Bonomi, M., Bouvattier, C., Perrière, A. Brac de la, Brucker, S., Cappa, M., Chanson, P., Claahsen-van der Grinten, H.L., Colao, A., Cools, M., Davies, J.H., Dörr, H.G., Fenske, W.K., Ghigo, E., Giordano, R., Gravholt, C.H., Huebner, A., Husebye, E.S., Igbokwe, R., Juul, A., Kiefer, F.W., Léger, J., Menassa, R., Meyer, G., Neocleous, V., Phylactou, L.A., Rohayem, J., Russo, G., Scaroni, C., Touraine, P., Unger, N., Vojtková, J., Yeste, D., Lajic, S., and Reisch, N.

Abstract

Contains fulltext : 283126.pdf (Publisher’s version ) (Open Access), OBJECTIVE: To assess the current medical practice in Europe regarding prenatal dexamethasone (Pdex) treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. DESIGN AND METHODS: A questionnaire was designed and distributed, including 17 questions collecting quantitative and qualitative data. Thirty-six medical centres from 14 European countries responded and 30 out of 36 centres were reference centres of the European Reference Network on Rare Endocrine Conditions, EndoERN. RESULTS: Pdex treatment is currently provided by 36% of the surveyed centres. The treatment is initiated by different specialties, that is paediatricians, endocrinologists, gynaecologists or geneticists. Regarding the starting point of Pdex, 23% stated to initiate therapy at 4-5 weeks postconception (wpc), 31% at 6 wpc and 46 % as early as pregnancy is confirmed and before 7 wpc at the latest. A dose of 20 µg/kg/day is used. Dose distribution among the centres varies from once to thrice daily. Prenatal diagnostics for treated cases are conducted in 72% of the responding centres. Cases treated per country and year vary between 0.5 and 8.25. Registries for long-term follow-up are only available at 46% of the centres that are using Pdex treatment. National registries are only available in Sweden and France. CONCLUSIONS: This study reveals a high international variability and discrepancy in the use of Pdex treatment across Europe. It highlights the importance of a European cooperation initiative for a joint international prospective trial to establish evidence-based guidelines on prenatal diagnostics, treatment and follow-up of pregnancies at risk for CAH.

Published
2022

17. CGM chez des patients DT2 insulinotraités switchés pour l’insuline icodec hebdomadaire vs comparateurs journaliers : post-hoc des études ONWARDS 2 et 4

Author

Zummo, F., Ásbjörnsdóttir, B., Bajaj, H.S., Laugesen, C., Mathieu, C., Philis-Tsimikas, A., Wang, N., and Battelino, T.

Abstract

Le temps passé dans, au-dessus et en dessous de la cible (TIR, TAR, TBR) de deux essais de phase 3 sur des patients DT2 sous insuline, randomisés à l’insuline hebdomadaire icodec a été étudié.

Published
2024
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27. Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries

Author

Danne, T., Battelino, T., Jarosz-Chobot, P., Kordonouri, O., Pánkowska, E., Ludvigsson, J., Schober, E., Kaprio, E., Saukkonen, T., Nicolino, M., Tubiana-Rufi, N., Klinkert, C., Haberland, H., Vazeou, A., Madacsy, L., Zangen, D., Cherubini, V., Rabbone, I., Toni, S., de Beaufort, C., Bakker-van Waarde, W., van den Berg, N., Volkov, I., Barrio, R., Hanas, R., Zumsteg, U., Kuhlmann, B., Aebi, C., Schumacher, U., Gschwend, S., Hindmarsh, P., Torres, M., Shehadeh, N., Phillip, M., and and the PedPump Study Group

Published
2008
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29. Durée d’hypoglycémie similaire avec icodec vs degludec ou glargine U100 chez les patients DT2 insulinotraités : analyse CGM post-hoc d’ONWARDS 2 et 4

Author

Zummo, F., Battelino, T., Ásbjörnsdóttir, B., Carstensen, L., Laugesen, C., Mathieu, C., Philis-Tsimikas, A., and Bajaj, H.S.

Abstract

icodec est une insuline basale hebdomaire qui a été étudiée dans le cadre du programme ONWARDS. Le temps passé en hypoglycémie pendant les périodes de switch (S0-4) et d’état d’équilibre (S22-26) de deux essais de phase 3 sur des patients DT2 sous insuline a été étudié.

Published
2024
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50. International Consensus on Risk Management of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Treated With Sodium-Glucose Cotransporter (SGLT) Inhibitors

Author

Danne T, Garg S, Peters A, Buse J, Mathieu C, Pettus J, Alexander C, Battelino T, Ampudia-Blasco F, Bode B, Cariou B, Close K, Dandona P, Dutta S, Ferrannini E, Fourlanos S, Grunberger G, Heller S, Henry R, Kurian M, Kushner J, Oron T, Parkin C, Pieber T, Rodbard H, Schatz D, Skyler J, Tamborlane W, Yokote K, and Phillip M

Published
2019

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