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NCT Number: NCT03528226

Exercise Training and Endothelial Function in Type 1 Diabetes

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

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Key information

Conditions

Type1diabetes Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training Procedure

Behavioral

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

Behavioral

No supervised exercise training during the 4 month period.

Primary outcomes

  1. Change in percent flow-mediated dilation (FMD) values

    Time frame: between baseline and at 4 months

Secondary outcomes

  1. Change the vascular responses

    Time frame: 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)

    -Vasoreactivity of the cutaneous capillaries of the forearm in response to acetylcholine and sodium nitroprusside (iontophoresis)

  2. Change the vascular responses

    Time frame: 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)

    -Dilatatory macrocirculation (brachial artery) and microcirculatory (capillaries of the hand) to nitroglycerine (in sublingual spraying)

  3. Change the vascular responses

    Time frame: 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

  4. Change in percent flow-mediated dilation (FMD) values

    Time frame: between baseline and at 2 months

  5. change the maximum oxygen consumption ( VO2max)

    Time frame: at baseline , at 2 months , at 4 months

  6. Change Blood marker concentrations of nitric oxide (NO)

    Time frame: at baseline , at 2 months , at 4 months

  7. change Blood concentration of neurotrophic factors

    Time frame: at baseline , at 2 months , at 4 months

    Blood concentration of neurotrophic factors and blood markers of metabolic profile

  8. Body composition (DEXA)

    Time frame: at baseline , at 2 months , at 4 months

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Vambergue, MD,PhD

CONTACT

[email protected]

320444184 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: EVaDia

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
May 17, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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