NCT02682706

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. 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. 2.Assess the intra-individual variance of BAT volume measured by MRI.
  3. 3.Evaluate direct measurement of BAT temperature by functional MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

February 10, 2016

Last Update Submit

April 5, 2018

Conditions

Keywords

brown adipose tissuemagnetic resonance imagingenergy expenditurenon-shivering thermogenesis

Outcome Measures

Primary Outcomes (1)

  • Correlation of scBAT volume and cold induced thermogenesis as determined by indirect calorimetry

    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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

University Hospital of Basel, Department of Radiology

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Senn JR, Maushart CI, Gashi G, Michel R, Lalive d'Epinay M, Vogt R, Becker AS, Muller J, Balaz M, Wolfrum C, Burger IA, Betz MJ. Outdoor Temperature Influences Cold Induced Thermogenesis in Humans. Front Physiol. 2018 Aug 23;9:1184. doi: 10.3389/fphys.2018.01184. eCollection 2018.

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

Study Officials

  • Matthias J Betz, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 6, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations