Exercise Training and Endothelial Function in Type 1 Diabetes
ConditionType1diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity Hospital, Lille
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Covered by social security
With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Training Procedure
BehavioralExercise 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
BehavioralNo supervised exercise training during the 4 month period.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Exercise TrainingExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in percent flow-mediated dilation (FMD) values
Time frame
between baseline and at 4 monthsSecondary outcomes
1
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)
Time frame
at baseline , at 2 months , at 4 months2
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)
Time frame
at baseline , at 2 months , at 4 months3
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
Time frame
at baseline , at 2 months , at 4 months4
Change in percent flow-mediated dilation (FMD) values
Time frame
between baseline and at 2 monthsSponsors and contacts
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Source ClinicalTrials.gov