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

Primary Purpose

Type1diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exercise Training Procedure
Normal life procedure
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type1diabetes focused on measuring Type 1 diabetes, endothelial function, exercise training, physical activity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercise Training

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in percent flow-mediated dilation (FMD) values

Secondary Outcome Measures

Change the vascular responses
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)
Change the vascular responses
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)
Change the vascular responses
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
Change in percent flow-mediated dilation (FMD) values
change the maximum oxygen consumption ( VO2max)
Change Blood marker concentrations of nitric oxide (NO)
change Blood concentration of neurotrophic factors
Blood concentration of neurotrophic factors and blood markers of metabolic profile
Body composition (DEXA)

Full Information

First Posted
May 3, 2018
Last Updated
February 6, 2023
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03528226
Brief Title
Exercise Training and Endothelial Function in Type 1 Diabetes
Acronym
EVaDia
Official Title
Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Type 1 diabetes, endothelial function, exercise training, physical activity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training Procedure
Intervention Description
Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months)
Intervention Type
Behavioral
Intervention Name(s)
Normal life procedure
Intervention Description
No supervised exercise training during the 4 month period.
Primary Outcome Measure Information:
Title
Change in percent flow-mediated dilation (FMD) values
Time Frame
between baseline and at 4 months
Secondary Outcome Measure Information:
Title
Change the vascular responses
Description
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)
Time Frame
at baseline , at 2 months , at 4 months
Title
Change the vascular responses
Description
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)
Time Frame
at baseline , at 2 months , at 4 months
Title
Change the vascular responses
Description
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
Time Frame
at baseline , at 2 months , at 4 months
Title
Change in percent flow-mediated dilation (FMD) values
Time Frame
between baseline and at 2 months
Title
change the maximum oxygen consumption ( VO2max)
Time Frame
at baseline , at 2 months , at 4 months
Title
Change Blood marker concentrations of nitric oxide (NO)
Time Frame
at baseline , at 2 months , at 4 months
Title
change Blood concentration of neurotrophic factors
Description
Blood concentration of neurotrophic factors and blood markers of metabolic profile
Time Frame
at baseline , at 2 months , at 4 months
Title
Body composition (DEXA)
Time Frame
at baseline , at 2 months , at 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Fontaine, MD,PhD
Phone
320445843
Ext
+33
Email
pierre.fontaine@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fontaine, MD,Phd
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

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Exercise Training and Endothelial Function in Type 1 Diabetes

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