Type 1 Diabetes MellitusNCT03506711
Isometric Handgrip Exercise -MRI in Children and Adolescents
A study testing Isometric Handgrip Exercise during magnetic resonance imaging in people with Type 1 Diabetes Mellitus and Coronary Artery Disease, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Coronary Artery Disease
- What is being tested?
- Isometric Handgrip Exercise during magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2016to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Type 1 Diabetes mellitus or
- Healthy community-dwelling children on no medications
Who cannot join
- smoking
- obesity (BMI >97th percentile)
- systolic or diastolic hypertension (>90th percentile)
- inflammatory process.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
About this study
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
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).
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, Coronary Artery Disease
- Being tested
- Isometric Handgrip Exercise during magnetic resonance imaging
- Keywords
- Type 1 Diabetes Mellitus, MRI, Isometric handgrip exercise, Children, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Handgrip Exercise during magnetic resonance imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| T1DM Children and adolescents | Active comparator | Children and adolescents with Type 1 Diabetes Mellitus Receives: Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging |
| Healthy Children and adolescents | Active comparator | Healthy community-dwelling children on no medication Receives: Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coronary cross sectional area (mm2)
Change from rest to that during isometric handgrip exercise (IHE).
Measured: Baseline and up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Feb 2016
- Primary completion30 Dec 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hauschild, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506711
- Sponsor's protocol ID
- CER-VD 213/15
- Status last verified
- Jun 2021
- First submitted
- 16 Mar 2018
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28261859Hays 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.
PubMed 23536782
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03506711
- Acronym / sponsor ID
- CER-VD 213/15
- Conditions
- Type 1 Diabetes Mellitus, Coronary Artery Disease
- Keywords
- Type 1 Diabetes Mellitus, MRI, Isometric handgrip exercise, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1DM Children and adolescents | Active comparator | Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imagingChildren and adolescents with Type 1 Diabetes Mellitus |
| Healthy Children and adolescents | Active comparator | Diagnostic Test: Isometric Handgrip Exercise during magnetic resonance imagingHealthy community-dwelling children on no medication |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 Diabetes mellitus or
- Healthy community-dwelling children on no medications
Key exclusion criteria (4 listed)
- smoking
- obesity (BMI >97th percentile)
- systolic or diastolic hypertension (>90th percentile)
- inflammatory process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric Handgrip Exercise during magnetic resonance imagingCoronary 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. | Diagnostic test | Healthy Children and adolescents, T1DM Children and adolescents |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Background: PubMed 28261859Yerly 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.
- Background: PubMed 23536782Hays 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Handgrip Exercise during magnetic resonance imaging in people with Type 1 Diabetes Mellitus and Coronary Artery Disease, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary cross sectional area (mm2) (time frame: Baseline and up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.