Clinical trial NCT03528226: Exercise Training and Endothelial Function in Type 1 Diabetes
Official title: Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1diabetes
Keywords: Type 1 diabetes
endothelial function
exercise training
physical activity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility 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

Primary outcomes:
measure: Change in percent flow-mediated dilation (FMD) values
timeFrame: between baseline and at 4 months
Secondary outcomes:
measure: Change the vascular responses
timeFrame: at baseline , at 2 months , at 4 months
measure: Change the vascular responses
timeFrame: at baseline , at 2 months , at 4 months
measure: Change the vascular responses
timeFrame: at baseline , at 2 months , at 4 months
measure: Change in percent flow-mediated dilation (FMD) values
timeFrame: between baseline and at 2 months
measure: change the maximum oxygen consumption ( VO2max)
timeFrame: at baseline , at 2 months , at 4 months
measure: Change Blood marker concentrations of nitric oxide (NO)
timeFrame: at baseline , at 2 months , at 4 months
measure: change Blood concentration of neurotrophic factors
timeFrame: at baseline , at 2 months , at 4 months
measure: Body composition (DEXA)
timeFrame: at baseline , at 2 months , at 4 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Pierre Fontaine, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References: