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Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data.
Gabriel, Rafael; Boukichou Abdelkader, Nisa; Acosta, Tania; Gilis-Januszewska, Aleksandra; Gómez-Huelgas, Ricardo; Makrilakis, Konstantinos; Kamenov, Zdravko; Paulweber, Bernhard; Satman, Ilhan; Djordjevic, Predrag; Alkandari, Abdullah; Mitrakou, Asimina; Lalic, Nebojsa; Colagiuri, Stephen; Lindström, Jaana; Egido, Jesús; Natali, Andrea; Pastor, J Carlos; Teuschl, Yvonne; Lind, Marcus; Silva, Luis; López-Ridaura, Ruy; Tuomilehto, Jaakko.
Afiliação
  • Gabriel R; Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain.
  • Boukichou Abdelkader N; World Community for Prevention of Diabetes Foundation (WCPD), Madrid, Spain.
  • Acosta T; EVIDEM CONSULTORES, Madrid, Spain.
  • Gilis-Januszewska A; Asociación para la Investigación y Prevención de la Diabetes y Enfermedades Cardiovasculares (PREDICOR), Madrid, Spain.
  • Gómez-Huelgas R; EVIDEM CONSULTORES, Madrid, Spain.
  • Makrilakis K; Department of Public Health. Universidad del Norte, Barranquilla, Colombia.
  • Kamenov Z; Uniwersytet Jagiellonski, Collegium Medicum, Krakow, Poland.
  • Paulweber B; Fundación FIMABIS. Servicio Andaluz de Salud (SAS), Malaga, Spain.
  • Satman I; National and Kapodistrian University of Athens, Athens, Greece.
  • Djordjevic P; University Multi-Profile Hospital for Active Treatment Alexandrovska EAD, Sofia, Bulgaria.
  • Alkandari A; Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft, (SALK) Salzburg, Austria.
  • Mitrakou A; Istanbul University, Istanbul, Turkey.
  • Lalic N; General Hospital Medical System Beograd-MSB Belgrade Serbia, Beograd, Serbia.
  • Colagiuri S; Dasman Diabetes Research Institute, Kuwait, Kuwait.
  • Lindström J; Alexandra Hospital, University of Athens, Athens, Greece.
  • Egido J; Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
  • Natali A; The University of Sydney, Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Sydney, Australia.
  • Pastor JC; National Institute for Health and Welfare, Helsinki, Finland.
  • Teuschl Y; Renal, Vascular and Diabetes Research Laboratory, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Universidad Autónoma, Madrid, Spain.
  • Lind M; Department of Internal Medicine, Universita di Pisa, Pisa, Italy.
  • Silva L; Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Hospital Clínico Universitario, Valladolid, Spain.
  • López-Ridaura R; Department for Clinical Neurosciences and Preventive Medicine, Danube University Krems, Krems, Austria.
  • Tuomilehto J; Västra Götalands Läns Landsting, Gothenburg, Sweden.
PLoS One ; 15(4): e0231196, 2020.
Article em En | MEDLINE | ID: mdl-32282852
OBJECTIVES: To assess the effects of early management of hyperglycaemia with antidiabetic drugs plus lifestyle intervention compared with lifestyle alone, on microvascular function in adults with pre-diabetes. METHODS: Trial design: International, multicenter, randomised, partially double-blind, placebo-controlled, clinical trial. PARTICIPANTS: Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey. INTERVENTION: Participants were randomized to placebo; metformin 1.700 mg/day; linagliptin 5 mg/day or fixed-dose combination of linagliptin/metformin. All patients were enrolled in a lifestyle intervention program (diet and physical activity). Drug intervention will last 2 years. Primary Outcome: composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index. Secondary outcomes in a subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function. RESULTS: One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin. A total of 809 people (91.1%) accepted and initiated the assigned treatment. Study sample after randomization was well balanced among the four groups. No statistical differences for the main risk factors analysed were observed between those accepting or rejecting treatment initiation. At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%. CONCLUSIONS: ePREDICE is the first -randomized clinical trial with the aim to assess effects of different interventions (lifestyle and pharmacological) on microvascular function in people with pre-diabetes. The trial will provide novel data on lifestyle modification combined with glucose lowering drugs for the prevention of early microvascular complications and diabetes. REGISTRATION: - ClinicalTrials.Gov Identifier: NCT03222765 - EUDRACT Registry Number: 2013-000418-39.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações do Diabetes / Diabetes Mellitus Tipo 2 / Hiperglicemia / Microcirculação Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged País/Região como assunto: Europa Idioma: En Revista: PLoS One Assunto da revista: CIENCIA / MEDICINA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Espanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações do Diabetes / Diabetes Mellitus Tipo 2 / Hiperglicemia / Microcirculação Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged País/Região como assunto: Europa Idioma: En Revista: PLoS One Assunto da revista: CIENCIA / MEDICINA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Espanha