Exercise Training and Endothelial Function in Type 1 Diabetes

Type1diabetes Clinical Trial

— EVaDia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528226
• Other study ID #: 2016_45.1
• Secondary ID: 2017-A02873-50
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: March 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Pierre Fontaine, MD,PhD
• Phone: 320445843
• Email: pierre.fontaine[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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)
• Normal life procedure
No supervised exercise training during the 4 month period.

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent flow-mediated dilation (FMD) values		between baseline and at 4 months
Secondary	Change the vascular responses	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
Secondary	Change the vascular responses	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
Secondary	Change the vascular responses	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
Secondary	Change in percent flow-mediated dilation (FMD) values		between baseline and at 2 months
Secondary	change the maximum oxygen consumption ( VO2max)		at baseline , at 2 months , at 4 months
Secondary	Change Blood marker concentrations of nitric oxide (NO)		at baseline , at 2 months , at 4 months
Secondary	change Blood concentration of neurotrophic factors	Blood concentration of neurotrophic factors and blood markers of metabolic profile	at baseline , at 2 months , at 4 months
Secondary	Body composition (DEXA)		at baseline , at 2 months , at 4 months