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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02682706
Other study ID # EKNZ BASEC 2015-00199
Secondary ID
Status Completed
Phase
First received February 10, 2016
Last updated April 5, 2018
Start date February 2016
Est. completion date March 2018

Study information

Verified date April 2018
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Hospital Basel, Department of Endocrinology Basel BS
Switzerland University Hospital of Basel, Department of Radiology Basel BS

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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