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

April 5, 2018 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

26

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
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel, Department of Endocrinology
      • Basel, BS, Switzerland, 4031
        • University Hospital of Basel, Department of Radiology

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
both measurements within 2 weeks

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

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)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKNZ BASEC 2015-00199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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