Exercise Training and Endothelial Function in Type 1 Diabetes (EVaDia)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Vambergue, MD,PhD
- Phone Number: +33 320444184
- Email: anne.vambergue@chu-lille.fr
Study Locations
-
-
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Lille, France, 59037
- Recruiting
- Hop Claude Huriez Chu Lille
-
Contact:
- Phone Number: 0320445962
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
|
No supervised exercise training during the 4 month period.
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Experimental: Exercise Training
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Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in percent flow-mediated dilation (FMD) values
Time Frame: between baseline and at 4 months
|
between baseline and at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change the vascular responses
Time Frame: at baseline , at 2 months , at 4 months
|
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
Time Frame: at baseline , at 2 months , at 4 months
|
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
Time Frame: at baseline , at 2 months , at 4 months
|
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
Time Frame: between baseline and at 2 months
|
between baseline and at 2 months
|
|
|
change the maximum oxygen consumption ( VO2max)
Time Frame: at baseline , at 2 months , at 4 months
|
at baseline , at 2 months , at 4 months
|
|
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Change Blood marker concentrations of nitric oxide (NO)
Time Frame: at baseline , at 2 months , at 4 months
|
at baseline , at 2 months , at 4 months
|
|
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change Blood concentration of neurotrophic factors
Time Frame: at baseline , at 2 months , at 4 months
|
Blood concentration of neurotrophic factors and blood markers of metabolic profile
|
at baseline , at 2 months , at 4 months
|
|
Body composition (DEXA)
Time Frame: at baseline , at 2 months , at 4 months
|
at baseline , at 2 months , at 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Vambergue, MD,Phd, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016_45.1
- 2017-A02873-50 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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