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Magnetic Resonance Imaging of Human Supraclavicular Brown Adipose Tissue - MIBAT Study (MIBAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682706
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

Brown adipose tissue (BAT) is unique in its capability to convert chemical energy directly into heat. Active BAT increases energy expenditure and can thereby counteract obesity and insulin resistance. Currently, the imaging method of choice to assess BAT morphology and function is 18F-FDG-PET/CT which is expensive and exposes patients or healthy volunteers to ionizing radiation, thus impeding larger prospective studies.

Magnetic resonance imaging (MRI) could constitute a suitable alternative and preliminary small-scale studies are promising.

The overall aim of this research proposal is to develop reliable magnetic resonance imaging techniques to facilitate the study of brown adipose tissue in human adults, specifically in the context of endocrine disease.

Specifically, investigators want to

  1. Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold induced nonshivering thermogenesis as a measure of BAT activity.
  2. Assess the intra-individual variance of BAT volume measured by MRI.
  3. Evaluate direct measurement of BAT temperature by functional MRI.

Condition or disease
Healthy

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging of Human Supraclavicular Brown Adipose Tissue - MIBAT Study
Actual Study Start Date : February 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation of scBAT volume and cold induced thermogenesis as determined by indirect calorimetry [ Time Frame: both measurements within 2 weeks ]
    measurement of scBAT volume and measurement of cold induced thermogenesis as determined by indirect calorimetry, both values measured in a timeframe of two weeks


Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-40 years
  • Body mass index (BMI): 17.5-27 kg/m²

Exclusion Criteria:

  • known concomitant disease influencing thyroid hormone metabolism
  • severe diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
  • known hypersensitivity to cold, e.g. primary or secondary Raynaud's syndrome
  • abuse of alcohol or illicit drugs
  • Women who are pregnant or breast feeding
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • implanted device not compatible with MRI, e.g. pace maker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682706


Locations
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Switzerland
University Hospital Basel, Department of Endocrinology
Basel, BS, Switzerland, 4031
University Hospital of Basel, Department of Radiology
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias J Betz, MD University Hospital, Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02682706    
Other Study ID Numbers: EKNZ BASEC 2015-00199
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Basel, Switzerland:
brown adipose tissue
magnetic resonance imaging
energy expenditure
non-shivering thermogenesis