Exercise Training and Endothelial Function in Type 1 Diabetes (EVaDia)

U

University Hospital, Lille

Status

Enrolling

Conditions

Type1diabetes

Treatments

Behavioral: Exercise Training Procedure
Behavioral: Normal life procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT03528226
2016_45.1
2017-A02873-50 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

34 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Exercise Training
Experimental group
Treatment:
Behavioral: Exercise Training Procedure
Control
Other group
Treatment:
Behavioral: Normal life procedure

Trial contacts and locations

1

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Central trial contact

Pierre Fontaine, MD,PhD

Data sourced from clinicaltrials.gov

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