Isometric Handgrip Exercise -MRI in Children and Adolescents
Primary Purpose
Type 1 Diabetes Mellitus, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Isometric Handgrip Exercise during magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, MRI, Isometric handgrip exercise, Children, Adolescents
Eligibility Criteria
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.
Sites / Locations
- Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
T1DM Children and adolescents
Healthy Children and adolescents
Arm Description
Children and adolescents with Type 1 Diabetes Mellitus
Healthy community-dwelling children on no medication
Outcomes
Primary Outcome Measures
Change in coronary cross sectional area (mm2)
Change from rest to that during isometric handgrip exercise (IHE).
Secondary Outcome Measures
Full Information
NCT ID
NCT03506711
First Posted
March 16, 2018
Last Updated
June 21, 2021
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03506711
Brief Title
Isometric Handgrip Exercise -MRI in Children and Adolescents
Official Title
Non-invasive Assessment of Endothelial Function in Children and Adolescents With Type 1 Diabetes Mellitus Using Isometric Handgrip Exercise -MRI: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Coronary Artery Disease
Keywords
Type 1 Diabetes Mellitus, MRI, Isometric handgrip exercise, Children, Adolescents
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T1DM Children and adolescents
Arm Type
Active Comparator
Arm Description
Children and adolescents with Type 1 Diabetes Mellitus
Arm Title
Healthy Children and adolescents
Arm Type
Active Comparator
Arm Description
Healthy community-dwelling children on no medication
Intervention Type
Diagnostic Test
Intervention Name(s)
Isometric Handgrip Exercise during magnetic resonance imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in coronary cross sectional area (mm2)
Description
Change from rest to that during isometric handgrip exercise (IHE).
Time Frame
Baseline and up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28261859
Citation
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.
Results Reference
background
PubMed Identifier
23536782
Citation
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.
Results Reference
background
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Isometric Handgrip Exercise -MRI in Children and Adolescents
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