Type1diabetesEVaDiaNCT03528226
Exercise Training and Endothelial Function in Type 1 Diabetes
A study testing Exercise Training Procedure and Normal life procedure in people with Type1diabetes, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Exercise Training Procedure and Normal life procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2019to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Covered by social security
- With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
About this study
Official title: Impact of Exercise Training on Endothelial Function in Adults With 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
- Conditions
- Type1diabetes
- Being tested
- Exercise Training Procedure, Normal life procedure
- Keywords
- Type 1 diabetes, endothelial function, exercise training, physical activity
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training ProcedureBehavioural
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 procedureBehavioural
No supervised exercise training during the 4 month period.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | Not described Receives: Behavioral: Exercise Training Procedure |
| Control | Other | Not described Receives: Behavioral: Normal life procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent flow-mediated dilation (FMD) values
Measured: between baseline and at 4 months
Secondary outcomes (8)
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)
Measured: at baseline , at 2 months , at 4 months
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)
Measured: at baseline , at 2 months , at 4 months
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
Measured: at baseline , at 2 months , at 4 months
Change in percent flow-mediated dilation (FMD) values
Measured: between baseline and at 2 months
change the maximum oxygen consumption ( VO2max)
Measured: at baseline , at 2 months , at 4 months
Change Blood marker concentrations of nitric oxide (NO)
Measured: at baseline , at 2 months , at 4 months
change Blood concentration of neurotrophic factors
Blood concentration of neurotrophic factors and blood markers of metabolic profile
Measured: at baseline , at 2 months , at 4 months
Body composition (DEXA)
Measured: at baseline , at 2 months , at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start12 Nov 2019
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Vambergue, MD,Phd, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528226
- Sponsor's protocol ID
- 2016_45.1
- Other IDs
- 2017-A02873-50
- Acronym
- EVaDia
- Status last verified
- May 2026
- First submitted
- 3 May 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03528226
- Acronym / sponsor ID
- EVaDia / 2016_45.1
- Conditions
- Type1diabetes
- Keywords
- Type 1 diabetes, endothelial function, exercise training, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Behavioral: Exercise Training Procedure |
| Control | Other | Behavioral: Normal life procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Covered by social security
- With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Training ProcedureExercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months) | Behavioural | Exercise Training |
| Normal life procedureNo supervised exercise training during the 4 month period. | Behavioural | Control |
Primary outcome
Change in percent flow-mediated dilation (FMD) values
Time frame: between baseline and at 4 months
8 secondary outcomes
Change the vascular responses
Time frame: at baseline , at 2 months , at 4 months
Change the vascular responses
Time frame: at baseline , at 2 months , at 4 months
Change the vascular responses
Time frame: at baseline , at 2 months , at 4 months
Change in percent flow-mediated dilation (FMD) values
Time frame: between baseline and at 2 months
change the maximum oxygen consumption ( VO2max)
Time frame: at baseline , at 2 months , at 4 months
Change Blood marker concentrations of nitric oxide (NO)
Time frame: at baseline , at 2 months , at 4 months
change Blood concentration of neurotrophic factors
Time frame: at baseline , at 2 months , at 4 months
Body composition (DEXA)
Time frame: at baseline , at 2 months , at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Vambergue, MD,Phd principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training Procedure and Normal life procedure in people with Type1diabetes, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Vambergue, MD,PhD (320444184 ext. +33, anne.vambergue@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent flow-mediated dilation (FMD) values (time frame: between baseline and at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.