Type1diabetes
Conditions
Keywords
Type 1 diabetes, endothelial function, exercise training, physical activity
Brief summary
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
Interventions
BEHAVIORALExercise 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)
BEHAVIORALNormal life procedure
No supervised exercise training during the 4 month period.
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in percent flow-mediated dilation (FMD) values | between baseline and at 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change the vascular responses | 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) |
| 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 | at baseline , at 2 months , at 4 months | Blood concentration of neurotrophic factors and blood markers of metabolic profile |
| Body composition (DEXA) | at baseline , at 2 months , at 4 months | — |
Countries
France
Contacts
CONTACTAnne Vambergue, MD,PhD
PRINCIPAL_INVESTIGATORAnne Vambergue, MD,Phd
University Hospital, Lille
Outcome results
None listed