EVaDia: Exercise Training and Endothelial Function in Type 1 Diabetes

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03528226

Collaborator

(none)

Enrollment

Location

Arms

63.6

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type1diabetes	Behavioral: Exercise Training Procedure Behavioral: Normal life procedure	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 12, 2019

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Training	Behavioral: Exercise 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)
Other: Control	Behavioral: Normal life procedure No supervised exercise training during the 4 month period.

Arm

Intervention/Treatment

Experimental: Exercise Training

Behavioral: Exercise 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)

Other: Control

Behavioral: Normal life procedure

No supervised exercise training during the 4 month period.

Outcome Measures

Primary Outcome Measures

Change in percent flow-mediated dilation (FMD) values [between baseline and at 4 months]

Secondary Outcome Measures

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 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) -Dilatatory macrocirculation (brachial artery) and microcirculatory (capillaries of the hand) to nitroglycerine (in sublingual spraying)
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) -Evolution of the blood volume at the vastus lateralis muscle and the prefrontal cortex in response to an incremental maximal exercise
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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