Isometric Handgrip Exercise -MRI in Children and Adolescents

Study Overview
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Brief Summary
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This project aims to assess coronary vessel response to isometric handgrip exercise (IHE) during magnetic resonance imaging (MRI) in children with T1D children and healthy controls. The investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic pulse wave velocity (PWV).

Detailed Description
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Background Type 1 diabetes mellitus (T1D) in children and adolescents is associated with significant cardiovascular morbidity and mortality. Early detection of vascular dysfunction is key to management yet assessment is invasive - which is particularly challenging when considering pediatric patient populations. Recently, a novel approach using isometric handgrip exercise (IHE) during magnetic resonance imaging (MRI) has been developed to evaluate coronary endothelial function in adults. This project aims to assess coronary vessel response to IHE using MRI in children with T1D children and healthy controls. In addition, the investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic pulse wave velocity (PWV). Community-dwelling healthy volunteers (<18 years-old) and children with type 1 diabetes mellitus (disease duration ≥ 5 years) are recruited. IHE-MRI studies are conducted and measurements are recorded at rest (baseline) and under stress (IHE at 30% maximal effort). Carotic Ultrasound and Sphygmocor CPV System are used to assess CIMT and PWV respectively. Student's T-tests are used to compare results between groups.

Official Title
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Non-invasive Assessment of Endothelial Function in Children and Adolescents With Type 1 Diabetes Mellitus Using Isometric Handgrip Exercise -MRI: A Feasibility Study

Conditions
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Type 1 Diabetes Mellitus, Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 Diabetes mellitus or Healthy community-dwelling children on no medications Exclusion Criteria: smoking obesity (BMI >97th percentile) systolic or diastolic hypertension (>90th percentile) inflammatory process.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T1DM Children and adolescents<br>Children and adolescents with Type 1 Diabetes Mellitus | Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging<br>* Coronary endothelial function are assessed by MRI with imaging studies done at baseline (at rest) and during IHE (under stress). Maximum grip strength is determined using an MRI-compatible dynamometer (Grip Force Fiber Optic Response Pad, Current Designs Inc., Philadelphia, USA) prior to baseline imaging.<br>|
| Active Comparator: Healthy Children and adolescents<br>Healthy community-dwelling children on no medication | Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging<br>* Coronary endothelial function are assessed by MRI with imaging studies done at baseline (at rest) and during IHE (under stress). Maximum grip strength is determined using an MRI-compatible dynamometer (Grip Force Fiber Optic Response Pad, Current Designs Inc., Philadelphia, USA) prior to baseline imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary cross sectional area (mm2) | Change from rest to that during isometric handgrip exercise (IHE). | Baseline and up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Type 1 Diabetes Mellitus, Isometric handgrip exercise, Children, Adolescents