NCT01921075

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. 1.assess the methodological reproducibility of MRS-measurements of cardiac lipids in humans
  2. 2.investigate physiological variations of cardiac lipids by measuring day-to-day changes under identical conditions
  3. 3.determining diurnal variations of cardiac lipids in humans

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

August 5, 2013

Last Update Submit

August 8, 2013

Conditions

Keywords

physiology, normal function

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

Other: normal dietary behaviorOther: Magnetic resonance spectroscopy

Interventions

normal dietary behavior during examination days

Volunteers

Non-invasive diagnostic procedure

Volunteers

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Institute of Diagnostic Interventional and Pediatric Radiology, University Hospital Bern

Bern, CH-3010, Switzerland

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ith, PhD & MD/PhD

    University Institute of Diagnostic Interventional and Pediatric Radiology of the Inselspital Bern

    PRINCIPAL INVESTIGATOR

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

Locations