Exercise Training and Endothelial Function in Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Type1diabetes
• Interventions: Behavioral: Exercise Training Procedure; Behavioral: Normal life procedure

• Registration Number: NCT03528226
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-17
• Study Start: 2019-11-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training	Exercise Training Procedure	-
Control	Normal life procedure	-

Primary Outcome Measures

Name	Time	Method
Change in percent flow-mediated dilation (FMD) values	between baseline and at 4 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France