Isometric Handgrip Exercise -MRI in Children and Adolescents

June 21, 2021 updated by: Michael Hauschild, University of Lausanne Hospitals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-VD 213/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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