Exercise Training and Endothelial Function in Type 1 Diabetes

Study Overview
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Brief Summary
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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

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

Conditions
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Type1diabetes

Intervention / Treatment
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* Behavioral: Exercise Training Procedure
* Behavioral: Normal life procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training<br> | Behavioral: Exercise Training Procedure<br>* Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months)<br>|
| Other: Control<br> | Behavioral: Normal life procedure<br>* No supervised exercise training during the 4 month period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent flow-mediated dilation (FMD) values |  | between baseline and at 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Change in percent flow-mediated dilation (FMD) values |  | between baseline and at 2 months | 
| change the maximum oxygen consumption ( VO2max) |  | at baseline , at 2 months , at 4 months | 
| Change Blood marker concentrations of nitric oxide (NO) |  | at baseline , at 2 months , at 4 months | 
| 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 | 
| Body composition (DEXA) |  | at baseline , at 2 months , at 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, endothelial function, exercise training, physical activity