Isometric Handgrip Exercise -MRI in Children and Adolescents

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506711
• Other study ID #: CER-VD 213/15
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2021
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in coronary cross sectional area (mm2)	Change from rest to that during isometric handgrip exercise (IHE).	Baseline and up to 3 years