Brown FatPhase 2MiraBATNCT02354807
Efficacy of Pharmacological Stimulation of BAT and WAT in Lean and Obese Young Adults
A Phase 2 study testing Mirabegron and Cold exposure in people with Brown Fat, run by Otto Muzik at 1 site in United States.
Trial summary
To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue (BAT or "Brown Fat") and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3 agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure to cold, the investigators will assess the… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Fat
- What is being tested?
- Mirabegron and Cold exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Mar 2018
- Phase
- Phase 2
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 25 kg/m2 or BMI > 30 kg/m2
- Able to give study-specific informed consent
- Able to tolerate PET/CT imaging required by protocol, to be performed without sedation and
- Patients who are not on sedative, antidepressant, sedative antihistaminic or narcotic medications.
Who cannot join
- Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding
- Subjects with cardiac disease or hypertension
- Subjects with history of diabetes
- Subjects with severe renal impairment or subjects with moderate hepatic impairment
- Subjects with severe uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Otto Muzik, PhD, 313-993-2616, otto@pet.wayne.edu
Cynthia Burnett, MS,CJ, 313-993-3848, cgburnet@med.wayne.edu
About this study
Official title: Efficacy of Pharmacological Stimulation of Brown and White Fat in Lean and Obese Young Adults
To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue (BAT or "Brown Fat") and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3 agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure to cold, the investigators will assess the efficacy of an FDA approved beta3 agonist Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) for increasing oxidative metabolism in supraclavicular BAT and subcutaneous WAT in lean and obese young adults.
The investigators anticipate that both methods to stimulate supraclavicular BAT and subcutaneous WAT will result in similar 18F-labeled fluoro-deoxyglucose (FDG) tracer uptake on positron emission tomography (PET) images as well as oxidative metabolism. This would demonstrate that pharmacological stimulation of BAT is effective and could lead to further, more detailed clinical trials in obese subjects.
Read the detailed description
Obesity and diabetes have increased to epidemic proportions in the US and in many other countries. In addition, the comorbidities of these metabolic diseases, such as cardiovascular disease, cancer, osteoarthritis are placing a huge burden on the health and health care system of the United States. Finding new avenues for human therapeutics is thus a critical challenge. Brown adipose tissue (BAT or "Brown Fat") functions to dissipate stored chemical energy in the form of heat and serves to defend mammals from hypothermia and obesity.
It is now firmly established that humans have functional BAT that can be activated by mild cold stress and imaged by 18F-labeled fluoro-deoxyglucose (FDG) PET imaging. Moreover, it is now understood that there are two distinct types of brown fat cells: the "classical" brown fat (most common in supraclavicular fat depots) that form developmentally from a muscle-like myf5-positive lineage and brown fat cells that can appear in white adipose tissue (WAT) depots upon prolonged exposure to cold or beta-adrenergic signaling. These latter cells originate from a myf5-negative lineage and are referred to as beige cells. Recent data suggests that most adult humans might have both brown and beige fat cells that are inactive but could be activated via the adrenergic system. Once activated, thermogenesis in these cells could affect the body's energy balance and might be instrumental in weight management.
Although adrenergic activation using cold exposure has been shown to be highly effective in activating both brown and beige fat cells, it is difficult to implement in daily routine and there is a need for other, more practical, interventions. Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) is a drug for the treatment of overactive bladder which was FDA approved in July of 2012. Mirabegron activates the beta3 adrenergic receptor in the detrusor muscle in the bladder, which leads to muscle relaxation and an increase in bladder capacity. There are reports of increased BAT FDG uptake following MIrabegron administration in both rodents and recently in humans. Because pharmacological stimulation of brown/beige fat cells might increase daily energy expenditure, this might represent a novel mechanism for weight management and eventually a new avenue for the treatment for obesity.
- Conditions
- Brown Fat
- Being tested
- Mirabegron, Cold exposure
- Keywords
- BAT activation, quantitative PET imaging, Mirabegron effect on BAT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Myrbetriq
One-time dose of 100mg of Mirabegron
Cold exposureOther
Exposure of subjects to cold temperature to induce non-shivering thermogenesis
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subjects that undergo both cold exposure and one-time dose of 100mg of Mirabegron drug Receives: Drug: Mirabegron; Other: Cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV as a measure of glucose metabolism
SUV value in supraclavicular BAT and subcutaneous WAT
Measured: 4 hours
Secondary outcomes (1)
Blood Flow
Blood Flow in supraclavicular BAT and subcutaneous WAT
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionMar 2018 (estimated)
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 Brown FatStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto Muzik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Otto Muzik, Wayne State University
- Investigators
- Otto Muzik, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354807
- Sponsor's protocol ID
- WSU_OVPR1
- Acronym
- MiraBAT
- Status last verified
- May 2017
- First submitted
- 22 Jan 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cypess AM, Weiner LS, Roberts-Toler C, Franquet Elia E, Kessler SH, Kahn PA, English J, Chatman K, Trauger SA, Doria A, Kolodny GM. Activation of human brown adipose tissue by a beta3-adrenergic receptor agonist. Cell Metab. 2015 Jan 6;21(1):33-8. doi: 10.1016/j.cmet.2014.12.009.
PubMed 25565203
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pharmacological Stimulation of Brown and White Fat in Lean and Obese Young Adults
- ClinicalTrials.gov ID
- NCT02354807
- Acronym / sponsor ID
- MiraBAT / WSU_OVPR1
- Conditions
- Brown Fat
- Keywords
- BAT activation, quantitative PET imaging, Mirabegron effect on BAT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Otto MuzikUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 3 Feb 2015 (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.
To determine whether pharmacological stimulation of supraclavicular Brown Adipose Tissue (BAT or "Brown Fat") and subcutaneous White Adipose Tissue (WAT) using an FDA-approved beta3 agonist is as effective in increasing oxidative metabolism in BAT and WAT as is the exposure to cold, the investigators will assess the efficacy of an FDA approved beta3 agonist Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) for increasing oxidative metabolism in supraclavicular BAT and subcutaneous WAT in lean and obese young adults.
The investigators anticipate that both methods to stimulate supraclavicular BAT and subcutaneous WAT will result in similar 18F-labeled fluoro-deoxyglucose (FDG) tracer uptake on positron emission tomography (PET) images as well as oxidative metabolism. This would demonstrate that pharmacological stimulation of BAT is effective and could lead to further, more detailed clinical trials in obese subjects.
Detailed description
Obesity and diabetes have increased to epidemic proportions in the US and in many other countries. In addition, the comorbidities of these metabolic diseases, such as cardiovascular disease, cancer, osteoarthritis are placing a huge burden on the health and health care system of the United States. Finding new avenues for human therapeutics is thus a critical challenge. Brown adipose tissue (BAT or "Brown Fat") functions to dissipate stored chemical energy in the form of heat and serves to defend mammals from hypothermia and obesity.
It is now firmly established that humans have functional BAT that can be activated by mild cold stress and imaged by 18F-labeled fluoro-deoxyglucose (FDG) PET imaging. Moreover, it is now understood that there are two distinct types of brown fat cells: the "classical" brown fat (most common in supraclavicular fat depots) that form developmentally from a muscle-like myf5-positive lineage and brown fat cells that can appear in white adipose tissue (WAT) depots upon prolonged exposure to cold or beta-adrenergic signaling. These latter cells originate from a myf5-negative lineage and are referred to as beige cells. Recent data suggests that most adult humans might have both brown and beige fat cells that are inactive but could be activated via the adrenergic system. Once activated, thermogenesis in these cells could affect the body's energy balance and might be instrumental in weight management.
Although adrenergic activation using cold exposure has been shown to be highly effective in activating both brown and beige fat cells, it is difficult to implement in daily routine and there is a need for other, more practical, interventions. Mirabegron (trade name Myrbetriq, Astellas Pharma, Inc.) is a drug for the treatment of overactive bladder which was FDA approved in July of 2012. Mirabegron activates the beta3 adrenergic receptor in the detrusor muscle in the bladder, which leads to muscle relaxation and an increase in bladder capacity. There are reports of increased BAT FDG uptake following MIrabegron administration in both rodents and recently in humans. Because pharmacological stimulation of brown/beige fat cells might increase daily energy expenditure, this might represent a novel mechanism for weight management and eventually a new avenue for the treatment for obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Mirabegron, Other: Cold exposureSubjects that undergo both cold exposure and one-time dose of 100mg of Mirabegron drug |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI < 25 kg/m2 or BMI > 30 kg/m2
- Able to give study-specific informed consent
- Able to tolerate PET/CT imaging required by protocol, to be performed without sedation and
- Patients who are not on sedative, antidepressant, sedative antihistaminic or narcotic medications.
Key exclusion criteria (5 listed)
- Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding
- Subjects with cardiac disease or hypertension
- Subjects with history of diabetes
- Subjects with severe renal impairment or subjects with moderate hepatic impairment
- Subjects with severe uncontrolled hypertension.
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 |
|---|---|---|
| MirabegronAlso: MyrbetriqOne-time dose of 100mg of Mirabegron | Drug | Experimental group |
| Cold exposureExposure of subjects to cold temperature to induce non-shivering thermogenesis | Other | Experimental group |
Primary outcome
SUV as a measure of glucose metabolism
Time frame: 4 hours
SUV value in supraclavicular BAT and subcutaneous WAT
1 secondary outcome
Blood Flow
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Results publication: PubMed 25565203Cypess AM, Weiner LS, Roberts-Toler C, Franquet Elia E, Kessler SH, Kahn PA, English J, Chatman K, Trauger SA, Doria A, Kolodny GM. Activation of human brown adipose tissue by a beta3-adrenergic receptor agonist. Cell Metab. 2015 Jan 6;21(1):33-8. doi: 10.1016/j.cmet.2014.12.009.
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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.
Otto Muzik principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron and Cold exposure in people with Brown Fat, run by Otto Muzik at 1 site in United States.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 May 2017. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Otto Muzik, PhD (313-993-2616, otto@pet.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV as a measure of glucose metabolism (time frame: 4 hours). 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 NCT02354807, 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 10 May 2017.