Exercise Training and Endothelial Function in Type 1 Diabetes

Официальное название

Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes

Обзор

Endothelial dysfunction and vasoreactivity disorders are early subclinical complications of type 1 diabetes (T1D). In a preventive setting, in T1D patients still free of complications, the research of non-pharmacological interventions to improve endothelial function appears fundamental. In this randomized controlled trial, the effects of exercise training on endothelial function will be evaluated in T1D adults. Secondary objectives are to evaluate the exercise training effects on the micro and macrovascular function and exercise-induced tissue vasoreactivity and their possible neurometabolic consequences. An improvement in vascular function, particularly endothelium-dependent, as well as in neurometabolic profile, through this non-pharmacological strategy is expected

Вмешательства

• Поведенческое Exercise Training Procedure
  Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months)
• Поведенческое Normal life procedure
  No supervised exercise training during the 4 month period.

Первичные конечные точки

• Change in percent flow-mediated dilation (FMD) values [Срок оценки: between baseline and at 4 months]

Вторичные конечные точки (8)

• Change the vascular responses [Срок оценки: at baseline , at 2 months , at 4 months]
• Change the vascular responses [Срок оценки: at baseline , at 2 months , at 4 months]
• Change the vascular responses [Срок оценки: at baseline , at 2 months , at 4 months]
• Change in percent flow-mediated dilation (FMD) values [Срок оценки: between baseline and at 2 months]
• change the maximum oxygen consumption ( VO2max) [Срок оценки: at baseline , at 2 months , at 4 months]
• Change Blood marker concentrations of nitric oxide (NO) [Срок оценки: at baseline , at 2 months , at 4 months]
• change Blood concentration of neurotrophic factors [Срок оценки: at baseline , at 2 months , at 4 months]
• Body composition (DEXA) [Срок оценки: at baseline , at 2 months , at 4 months]

Критерии участия

Критерии включения

• Covered by social security
• With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.

Критерии исключения

• type 1 diabetes diagnoses for less than 1 year
• MODY diabetes, mitochondrial diabetes or type 2 diabetes
• presence of macrovascular and/or microvascular diabetic complications (retinopathy, nephropathy, neuropathy ,…)
• Obesity (Body Mass Index > 30 kg/m²
• Smokers
• Hypertension
• Disabling painful discomfort for trunk, upper or lower limb movements
• Active chronic disease or in remission (excluding type 1 diabetes)
• Head trauma in the past

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Hop Claude Huriez Chu Lille — Lille

Идентификаторы

NCT: NCT03528226 · 2016_45.1 · 2017-A02873-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗