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

Exercise Training and Endothelial Function in Type 1 Diabetes

Sponsors

Lead sponsor: University Hospital, Lille

Source University Hospital, Lille
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

Overall Status Not yet recruiting
Start Date December 2019
Completion Date March 2025
Primary Completion Date March 2025
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in percent flow-mediated dilation (FMD) values between baseline and at 4 months
Secondary Outcome
Measure Time Frame
Change the vascular responses at baseline , at 2 months , at 4 months
Change the vascular responses at baseline , at 2 months , at 4 months
Change the vascular responses 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 at baseline , at 2 months , at 4 months
Body composition (DEXA) at baseline , at 2 months , at 4 months
Enrollment 34
Condition
Intervention

Intervention type: Behavioral

Intervention name: Exercise Training Procedure

Description: Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months)

Arm group label: Exercise Training

Intervention type: Behavioral

Intervention name: Normal life procedure

Description: No supervised exercise training during the 4 month period.

Arm group label: Control

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pierre Fontaine, MD,Phd Principal Investigator University Hospital, Lille
Overall Contact

Last name: Pierre Fontaine, MD,PhD

Phone: 320445843

Phone ext: +33

Email: [email protected]

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Exercise Training

Arm group type: Experimental

Arm group label: Control

Arm group type: Other

Acronym EVaDia
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov