Exercise Training and Endothelial Function in Type 1 Diabetes (EVaDia)

February 6, 2023 updated by: University Hospital, Lille

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control
Behavioral: Normal life procedure
No supervised exercise training during the 4 month period.
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)

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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 12, 2019

Primary Completion (ANTICIPATED)

March 1, 2025

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (ACTUAL)

May 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_45.1
  • 2017-A02873-50 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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