Exercise to improve blood vessel (endothelial) function in type 1 diabetes
Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes
This trial will test whether a supervised exercise program can improve blood vessel function in adults with type 1 diabetes who do not yet have complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT03528226 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing a structured exercise training program with usual life in adults with type 1 diabetes who are free of microvascular and macrovascular complications. Participants meeting strict inclusion and exclusion criteria will be assigned to supervised exercise sessions or to continue their normal activities. The primary outcome is change in endothelial function, and secondary outcomes include measures of micro- and macrovascular function, exercise-induced tissue vasoreactivity, and related neurometabolic changes. The approach is a non-pharmacological, preventive strategy aimed at improving early vascular health in this population.
Who should consider this trial
Good fit: Adults with type 1 diabetes diagnosed at least one year, without microvascular or macrovascular diabetic complications, who are non-smokers, not obese (BMI <30 kg/m²), without hypertension or other active chronic diseases, and able to perform trunk and limb movements are the ideal candidates.
Not a fit: Patients who already have diabetic microvascular or macrovascular complications, who have obesity, smoke, have uncontrolled hypertension, other active chronic diseases, or who have non–type 1 forms of diabetes are unlikely to benefit from this preventive exercise program.
Why it matters
Potential benefit: If successful, the exercise program could improve endothelial and overall vascular health and help delay or reduce early vascular complications in people with type 1 diabetes.
How similar studies have performed: Exercise interventions have improved endothelial function in other populations and small studies in type 1 diabetes suggest benefit, but larger randomized data in complication-free adults with type 1 diabetes remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Pierre Fontaine, MD,Phd — University Hospital, Lille
- Study coordinator: Pierre Fontaine, MD,PhD
- Email: pierre.fontaine@chru-lille.fr
- Phone: 320445843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.