Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can brown fat help burn calories? new study investigates

NCT ID NCT03049462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 12 times

Summary

This study looks at brown adipose tissue (BAT), a type of body fat that may help burn energy and improve metabolism. Researchers want to understand how BAT works and how it changes when people take a drug called mirabegron. The study involves 100 adults aged 18-40 with a BMI between 18 and 40, including women with PCOS. Participants take pills daily for 4 weeks and undergo tests like scans, exercise tests, and metabolic monitoring to measure changes in BAT activity and overall health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

55 people

The number who actually took part.

Started

Mar 2017

Finished

Aug 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: Cohort 1: (complete) 1. Female 2. Age 18-40 years 3. BMI 18.00-40.0 kg/m\^2 4. Able to understand the research and willing to sign a written informed consent document Cohort 2: (complete) 1. Male 2. Age 18-40 years 3. BMI 18.00-40.0 kg/m\^2 4. Able to understand the research and willing to sign a written informed consent document Cohort 3: 1. Female 2. Age 18-40 years 3. BMI 25.0-50.0 kg/m\^2 or BMI \> 18.5 kg/m\^2 with PCOS diagnosis 4. Diagnosis of PCOS based on NIH Criteria; defined by the presence of both clinical and/or biochemical signs of hyperandrogenism and oligo- or chronic anovulation. 5. Women of childbearing potential must agree to use a highly effective method of birth control, confirmed by the Investigator, for at least 3 months prior to the first study visit and continuing throughout the study duration. a. Highly effective methods of birth control include: i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable iii. Intrauterine device iv. Intrauterine hormone-releasing system v. Bilateral tubal occlusion vi. Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant) vii. Vasectomized sexual partner (provided that partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical assessment of the surgical success) b. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for \>=12 months prior to the planned date of enrollment without an alternative medical cause. 6. Insulin resistance defined by either 1. HOMA-IR score \> 5.9 OR 2. HOMA-IR score \> 2.8 and \<5.9, with HDL \<51 mg/dL OR 3. Fasting Insulin \> 10.6 microU/mL 7. Able to understand the research and willing to sign a written informed consent document EXCLUSION CRITERIA 1. Hypersensitivity and associated allergic reactions to mirabegron (or similar drug substances or components) 2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB) 3. Type 1 or Type 2 Diabetes mellitus, fasting serum glucose \>125 mg/dL, and/or an HbA1c test \>6.5% 4. Hypertension, defined as blood pressure (Bullet)140/90 mmHg, based on WHO guidelines (https://www.who.int/news-room/fact-sheets/detail/hypertension) 5. Hypo- or hyper-thyroid disease (TSH \>5.0, \<0.4 miU/L) that is controlled for less than one year 6. Anemia, defined by hemoglobin \< 11.3 g/dL (females) or \< 13.8 g/dL (males); sickle cell anemia or other blood disorders; and/or wound healing problems 7. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment 8. A clinically significant abnormal ECG and/or QTc interval above normal 9. Elevated liver enzymes with probable or diagnosed liver disease (other than fatty liver disease) 10. Psychological conditions such as claustrophobia, untreated clinical depression or anxiety, untreated bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study 11. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics 12. Self-reported intolerance of cold that would prevent the individual from spending several hours in a chilled room with a cooling vest 13. Current use of any drugs known to: * have major drug-drug interactions with mirabegron * Prolong QT interval * Alter glucose metabolism or cause insulin resistance (in last six months) * Treat diabetes mellitus * Treat hypertension * Be drugs of abuse 14. Self-reported weight loss or weight gain \> 5% in the preceding 6 months. 15. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months 16. Individuals who spend \>70% of daily hours outdoors since the exposure to varied environmental temperatures will potentially impact the ability to influence and measure BAT activity. 17. Addiction to alcohol or substances of abuse within the last 5 years 18. Self-reported current alcohol consumption of more than 2 servings of alcohol per day 19. Self-reported current use of nicotine and/or tobacco products 20. Has participated in a clinical trial with an investigational or marketed drug within 2 months 21. Have had previous radiation exposure (X-rays, PET scans, etc.) within the last year or anticipate radiation exposure in the upcoming year - clinical and/or research - that would exceed research limits 22. Donated blood within last 2 months 23. Unwilling or unable to eat metabolic meals, as determined by dietitian consult. 24. Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Polycystic ovary syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.