Exercise Training and Endothelial Function in Type 1 Diabetes

NCT03528226 | Recruiting

• 2 other identifiers: 2016_45.12017-A02873-50
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Type1diabetes

Keywords

Type 1 diabetes; endothelial function; exercise training; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in percent flow-mediated dilation (FMD) values

  between baseline and at 4 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Exercise Training

EXPERIMENTAL

Behavioral: Exercise Training Procedure

Control

OTHER

Behavioral: Normal life procedure

Interventions

Exercise Training Procedure BEHAVIORAL

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

Exercise Training

Normal life procedure BEHAVIORAL

No supervised exercise training during the 4 month period.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Covered by social security
• With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Pierre Fontaine, MD,Phd

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Fontaine, MD,PhD

CONTACT

320445843; pierre.fontaine@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 17, 2018
• Study Start: November 12, 2019
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)