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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528226
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: Exercise Training Procedure Behavioral: Normal life procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Training 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)

Control Behavioral: Normal life procedure
No supervised exercise training during the 4 month period.




Primary Outcome Measures :
  1. Change in percent flow-mediated dilation (FMD) values [ Time Frame: between baseline and at 4 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528226


Contacts
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Contact: Pierre Fontaine, MD,PhD 320445843 ext +33 pierre.fontaine@chru-lille.fr

Locations
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France
Hop Claude Huriez Chu Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Pierre Fontaine, MD,Phd University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03528226    
Other Study ID Numbers: 2016_45.1
2017-A02873-50 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Type 1 diabetes
endothelial function
exercise training
physical activity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases