Brown Adipose TissuePhase 4GlucoBATNCT03269747
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
A Phase 4 study testing Prednisone in people with Brown Adipose Tissue, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Dec 2017to 16 Apr 2019
- Phase
- Phase 4
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- BMI between 19-27 kg/m2
Who cannot join
- Cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- History of depressive disorder, anxiety disorder
- History of tuberculosis or latent infection
- Increased intraocular pressure
- History of peptic / gastrointestinal ulcer disease
Show all 19Show fewer
- Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), other glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
- Hypersensitivity to cold (e.g. Raynaud Syndrome)
- Allergy to local anesthetic
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Hypothyroidism without sufficient substitution
- Claustrophobia
- MRI incompatible implants
- Enrolment into another study using ionizing radiation within the previous 12 months.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
About this study
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
Read the detailed description
Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults. Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use of glucocorticoids (GCs) is widespread in clinical practice due to their high anti-inflammatory efficacy. While short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance.
In line with these well-known side-effects of GCs, several in vitro studies and animal models demonstrate an inhibiting effect of GCs on BAT thermogenesis.
- Conditions
- Brown Adipose Tissue
- Being tested
- Prednisone, Placebo
- Keywords
- glucocorticoids, brown adipose tissue, cold induced thermogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
2 tablets of Prednisone 20 Mg in the morning
PlaceboDrug
2 Placebo tablets in the morning
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Prednisone 40 mg daily for 7 days Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Placebo daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold induced thermogenesis
: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus determined by indirect calorimetry
Measured: at the end of each treatment period (day 7). Prednisone vs. Placebo
Secondary outcomes (4)
fat fraction of supraclavicular BAT
determined by MRI
Measured: at the end of each treatment period (day 7). Prednisone vs. Placebo
volume of supraclavicular BAT
determined by MRI
Measured: at the end of each treatment period (day 7). Prednisone vs. Placebo
cold stimulated FGD uptake in brown adipose tissue
determined as SUVmean by FDG-PET/CT
Measured: at the end of each treatment period (day 7). Prednisone vs. Placebo
SUVmax in the supraclavicular adipose tissue depot
determined by FDG-PET/CT
Measured: at the end of each treatment period (day 7). Prednisone vs. Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start6 Dec 2017
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brown Adipose TissueStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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
- NCT03269747
- Sponsor's protocol ID
- EKNZ 2016-01859
- Acronym
- GlucoBAT
- Status last verified
- Jun 2019
- First submitted
- 30 Aug 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maushart CI, Sun W, Othman A, Ghosh A, Senn JR, Fischer JGW, Madoerin P, Loeliger RC, Benz RM, Takes M, Zech CJ, Chirindel A, Beuschlein F, Reincke M, Wild D, Bieri O, Zamboni N, Wolfrum C, Betz MJ. Effect of high-dose glucocorticoid treatment on human brown adipose tissue activity: a randomised, double-blinded, placebo-controlled cross-over trial in healthy men. EBioMedicine. 2023 Oct;96:104771. doi: 10.1016/j.ebiom.2023.104771. Epub 2023 Sep 4.
PubMed 37659283Fischer JGW, Maushart CI, Becker AS, Muller J, Madoerin P, Chirindel A, Wild D, Ter Voert EEGW, Bieri O, Burger I, Betz MJ. Comparison of [18F]FDG PET/CT with magnetic resonance imaging for the assessment of human brown adipose tissue activity. EJNMMI Res. 2020 Jul 22;10(1):85. doi: 10.1186/s13550-020-00665-7.
PubMed 32699996
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
- ClinicalTrials.gov ID
- NCT03269747
- Acronym / sponsor ID
- GlucoBAT / EKNZ 2016-01859
- Conditions
- Brown Adipose Tissue
- Keywords
- glucocorticoids, brown adipose tissue, cold induced thermogenesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 1 Sep 2017 (actual)
- 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.
Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.
Detailed description
Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults. Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use of glucocorticoids (GCs) is widespread in clinical practice due to their high anti-inflammatory efficacy. While short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance.
In line with these well-known side-effects of GCs, several in vitro studies and animal models demonstrate an inhibiting effect of GCs on BAT thermogenesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: PrednisonePrednisone 40 mg daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily for 7 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers
- BMI between 19-27 kg/m2
Key exclusion criteria (19 listed)
- Cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- History of depressive disorder, anxiety disorder
- History of tuberculosis or latent infection
- Increased intraocular pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone2 tablets of Prednisone 20 Mg in the morning | Drug | Prednisone |
| Placebo2 Placebo tablets in the morning | Drug | Placebo |
Primary outcome
Cold induced thermogenesis
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
: Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus determined by indirect calorimetry
4 secondary outcomes
fat fraction of supraclavicular BAT
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
volume of supraclavicular BAT
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
cold stimulated FGD uptake in brown adipose tissue
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
SUVmax in the supraclavicular adipose tissue depot
Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo
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 5 Jun 2019.
- Derived from this study: PubMed 37659283Maushart CI, Sun W, Othman A, Ghosh A, Senn JR, Fischer JGW, Madoerin P, Loeliger RC, Benz RM, Takes M, Zech CJ, Chirindel A, Beuschlein F, Reincke M, Wild D, Bieri O, Zamboni N, Wolfrum C, Betz MJ. Effect of high-dose glucocorticoid treatment on human brown adipose tissue activity: a randomised, double-blinded, placebo-controlled cross-over trial in healthy men. EBioMedicine. 2023 Oct;96:104771. doi: 10.1016/j.ebiom.2023.104771. Epub 2023 Sep 4.
- Derived from this study: PubMed 32699996Fischer JGW, Maushart CI, Becker AS, Muller J, Madoerin P, Chirindel A, Wild D, Ter Voert EEGW, Bieri O, Burger I, Betz MJ. Comparison of [18F]FDG PET/CT with magnetic resonance imaging for the assessment of human brown adipose tissue activity. EJNMMI Res. 2020 Jul 22;10(1):85. doi: 10.1186/s13550-020-00665-7.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Brown Adipose Tissue, run by University Hospital, Basel, Switzerland at 1 site 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 2 inclusion and 19 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cold induced thermogenesis (time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo). 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 NCT03269747, which also lists 2 linked publications.
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 5 Jun 2019.