Type1diabetes Clinical Trial
— EVaDiaOfficial title:
Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes
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
Status | Recruiting |
Enrollment | 34 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Covered by social security - With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hop Claude Huriez Chu Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in percent flow-mediated dilation (FMD) values | between baseline and at 4 months | ||
Secondary | Change the vascular responses | Endothelium-dependent vasodilation capacity induced by post-occlusive reactive hyperaemia (5min occlusion) at the level of microcirculation (skin capillaries and arterioles of the hand) -Vasoreactivity of the cutaneous capillaries of the forearm in response to acetylcholine and sodium nitroprusside (iontophoresis) |
at baseline , at 2 months , at 4 months | |
Secondary | Change the vascular responses | Endothelium-dependent vasodilation capacity induced by post-occlusive reactive hyperaemia (5min occlusion) at the level of microcirculation (skin capillaries and arterioles of the hand) -Dilatatory macrocirculation (brachial artery) and microcirculatory (capillaries of the hand) to nitroglycerine (in sublingual spraying) |
at baseline , at 2 months , at 4 months | |
Secondary | Change the vascular responses | Endothelium-dependent vasodilation capacity induced by post-occlusive reactive hyperaemia (5min occlusion) at the level of microcirculation (skin capillaries and arterioles of the hand) -Evolution of the blood volume at the vastus lateralis muscle and the prefrontal cortex in response to an incremental maximal exercise |
at baseline , at 2 months , at 4 months | |
Secondary | Change in percent flow-mediated dilation (FMD) values | between baseline and at 2 months | ||
Secondary | change the maximum oxygen consumption ( VO2max) | at baseline , at 2 months , at 4 months | ||
Secondary | Change Blood marker concentrations of nitric oxide (NO) | at baseline , at 2 months , at 4 months | ||
Secondary | change Blood concentration of neurotrophic factors | Blood concentration of neurotrophic factors and blood markers of metabolic profile | at baseline , at 2 months , at 4 months | |
Secondary | Body composition (DEXA) | at baseline , at 2 months , at 4 months |
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