Isometric Handgrip Exercise -MRI in Children and Adolescents
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: T1DM Children and adolescents Children and adolescents with Type 1 Diabetes Mellitus |
Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging
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.
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| Active Comparator: Healthy Children and adolescents Healthy community-dwelling children on no medication |
Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging
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.
|
Outcome Measures
Primary Outcome Measures
- Change in coronary cross sectional area (mm2) [Baseline and up to 3 years]
Change from rest to that during isometric handgrip exercise (IHE).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 1 Diabetes mellitus or
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Healthy community-dwelling children on no medications
Exclusion Criteria:
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smoking
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obesity (BMI >97th percentile)
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systolic or diastolic hypertension (>90th percentile)
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inflammatory process.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital | Lausanne | Vaud | Switzerland | 1011 |
Sponsors and Collaborators
- University of Lausanne Hospitals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Hays AG, Stuber M, Hirsch GA, Yu J, Schär M, Weiss RG, Gerstenblith G, Kelle S. Non-invasive detection of coronary endothelial response to sequential handgrip exercise in coronary artery disease patients and healthy adults. PLoS One. 2013;8(3):e58047. doi: 10.1371/journal.pone.0058047. Epub 2013 Mar 11.
- Yerly J, Gubian D, Knebel JF, Schenk A, Chaptinel J, Ginami G, Stuber M. A phantom study to determine the theoretical accuracy and precision of radial MRI to measure cross-sectional area differences for the application of coronary endothelial function assessment. Magn Reson Med. 2018 Jan;79(1):108-120. doi: 10.1002/mrm.26646. Epub 2017 Mar 5.
- CER-VD 213/15