Physiologic Plasticity of Intramyocardial Lipid Storage
Patterns and Plasticity of Orthotopic and Ectopic Fat Deposition and Associations With Insulin Sensitivity: A Magnetic-resonance-imaging and -Spectroscopy Study in Lean and Obese Individuals: Methodological Part
2 other identifiers
observational
9
1 country
1
Brief Summary
The main goal of the present study was to provide a technical basis for future studies assessing the role of cardiac lipids. More specifically, non-invasive MR-Spectroscopy (MRS) techniques will be used in this study to:
- 1.assess the methodological reproducibility of MRS-measurements of cardiac lipids in humans
- 2.investigate physiological variations of cardiac lipids by measuring day-to-day changes under identical conditions
- 3.determining diurnal variations of cardiac lipids in humans
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 5, 2013
CompletedFirst Posted
Study publicly available on registry
August 13, 2013
CompletedAugust 13, 2013
August 1, 2013
1.9 years
August 5, 2013
August 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intramyocardial lipid content
at baseline (morning of examination day 1)
Secondary Outcomes (6)
Intramyocardial lipid content
evening of examination day 1, i.e. 8 hours after baseline
Intramyocardial lipid content
morning of examination day 2, i.e. 7 days after baseline
Intramyocardial lipid content
evening of examination day 2, i.e. 7 days & 8 hours after baseline
Intra-individual variation of intramyocardial lipid content
evening of examination day one, i.e. 8 hours after baseline
Intra-individual variation of intramyocardial lipid content
evening of examination day two, i.e. 7 days & 8 hours after baseline
- +1 more secondary outcomes
Study Arms (1)
Volunteers
young (age\<30), healthy, lean (BMI\<25) volunteers
Interventions
Eligibility Criteria
males between the age of 18 and 30 years with either a BMI of 18-24
You may qualify if:
- male
- age 18-30
- BMI \<25
- healthy
- written informed consent
You may not qualify if:
- contraindications to MRI examinations (claustrophobia, implanted devices (pacemaker, insulin pump, neurostimulators))
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- Takedacollaborator
Study Sites (1)
Institute of Diagnostic Interventional and Pediatric Radiology, University Hospital Bern
Bern, CH-3010, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ith, PhD & MD/PhD
University Institute of Diagnostic Interventional and Pediatric Radiology of the Inselspital Bern
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2013
First Posted
August 13, 2013
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 13, 2013
Record last verified: 2013-08