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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02873-50 | Other Identifier | ID-RCB number, ANSM |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Training | Experimental |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training Procedure | Behavioral | Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent flow-mediated dilation (FMD) values | between baseline and at 4 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Vambergue, MD,PhD | Contact | 320444184 | +33 | anne.vambergue@chu-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne Vambergue, MD,Phd | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Normal life procedure | Behavioral | No supervised exercise training during the 4 month period. |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |