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Exercise Training and Endothelial Function in Type 1 Diabetes

NCT ID: NCT03528226

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2026-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Type1diabetes

Keywords

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Type 1 diabetes endothelial function exercise training physical activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Exercise Training

Group Type EXPERIMENTAL

Exercise Training Procedure

Intervention Type 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)

Control

Group Type OTHER

Normal life procedure

Intervention Type BEHAVIORAL

No supervised exercise training during the 4 month period.

Interventions

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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)

Intervention Type BEHAVIORAL

Normal life procedure

No supervised exercise training during the 4 month period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Fontaine, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Fontaine, MD,PhD

Role: CONTACT

Phone: 320445843

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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2017-A02873-50

Identifier Type: OTHER

Identifier Source: secondary_id

2016_45.1

Identifier Type: -

Identifier Source: org_study_id