Isometric Handgrip Exercise -MRI in Children and Adolescents
NCT ID: NCT03506711
Last Updated: 2021-06-22
Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-02-01
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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T1DM Children and adolescents
Children and adolescents with Type 1 Diabetes Mellitus
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.
Healthy Children and adolescents
Healthy community-dwelling children on no medication
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Healthy community-dwelling children on no medications
Exclusion Criteria
* obesity (BMI \>97th percentile)
* systolic or diastolic hypertension (\>90th percentile)
* inflammatory process.
8 Years
18 Years
ALL
Yes
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Michael Hauschild
Head of clinical pediatric endocrinology diabetology unit
Locations
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Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
Countries
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References
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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.
Hays AG, Stuber M, Hirsch GA, Yu J, Schar 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.
Other Identifiers
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CER-VD 213/15
Identifier Type: -
Identifier Source: org_study_id
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