HealthyMIBATNCT02682706
Magnetic Resonance Imaging of Human Supraclavicular Brown Adipose Tissue - MIBAT Study
An observational study of Healthy, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 26 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers
Who may be able to join
- Healthy volunteers
- Age 18-40 years
- Body mass index (BMI): 17.5-27 kg/m²
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
University Hospital of Basel, Department of Radiology
Basel, Canton of Basel-City, 4031
About this study
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.
Read more
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
- Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold induced nonshivering thermogenesis as a measure of BAT activity.
- Assess the intra-individual variance of BAT volume measured by MRI.
- Evaluate direct measurement of BAT temperature by functional MRI.
- Conditions
- Healthy
- Keywords
- brown adipose tissue, magnetic resonance imaging, energy expenditure, non-shivering thermogenesis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: both measurements within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias J Betz, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682706
- Sponsor's protocol ID
- EKNZ BASEC 2015-00199
- Acronym
- MIBAT
- Status last verified
- Apr 2018
- First submitted
- 10 Feb 2016
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30190681
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Human Supraclavicular Brown Adipose Tissue - MIBAT Study
- ClinicalTrials.gov ID
- NCT02682706
- Acronym / sponsor ID
- MIBAT / EKNZ BASEC 2015-00199
- Conditions
- Healthy
- Keywords
- brown adipose tissue, magnetic resonance imaging, energy expenditure, non-shivering thermogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold induced nonshivering thermogenesis as a measure of BAT activity.
- Assess the intra-individual variance of BAT volume measured by MRI.
- Evaluate direct measurement of BAT temperature by functional MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (3 listed)
- Healthy volunteers
- Age 18-40 years
- Body mass index (BMI): 17.5-27 kg/m²
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 30190681Senn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias J Betz, MD principal investigator
University Hospital, Basel, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of scBAT volume and cold induced thermogenesis as determined by indirect calorimetry (time frame: both measurements within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.