[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100289569":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":79,"collaborators":38,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":38,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":38,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":61,"whyStopped":38,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,14,19,25,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Females taking 100 mg of mirabegron",[13],"Drug: Mirabegron",{"label":15,"type":16,"description":17,"interventionNames":18},"Cohort 2A","ACTIVE_COMPARATOR","Males taking 200 mg mirabegron",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Cohort 2B","PLACEBO_COMPARATOR","Males taking placebo drug",[24],"Other: B Complex Plus Vitamin C Tablets",{"label":26,"type":16,"description":11,"interventionNames":27},"Cohort 3A",[13],{"label":29,"type":21,"description":30,"interventionNames":31},"Cohort 3B","Females taking placebo drug",[24],[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Mirabegron","Women will take 100mg daily for 4 weeks. Men will take 200mg daily for 4 weeks. The medication is available in 50 mg tablets.",[9,15,26],null,{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":38},"OTHER","B Complex Plus Vitamin C Tablets","Males will be randomized to take placebo versus active drug (mirabegron). Those taking placebo will take 4 tablets each day to mirror to active group (taking 4 tablets of 50 mg each).",[20,29],[45],{"name":46,"affiliation":47,"role":48},"Aaron M Cypess, M.D.","National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":38,"email":54},"Ashley M Schmitz, C.R.N.P.","CONTACT","(920) 948-1186","ashley.schmitz@nih.gov",{"name":46,"role":52,"phone":56,"phoneExt":38,"email":57},"(301) 435-9267","aaron.cypess@nih.gov",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-77.10026,38.98067,{"lat":71,"lon":70},[74],{"name":75,"role":52,"phone":76,"phoneExt":77,"email":78},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY8664111010","prpl@cc.nih.gov",{"type":80,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100289569","phase-1-the-physiological-responses-and-adaptation-of-brown-adipose-tissue-to-chronic-treatment-with-beta3-adrenergic-receptor-agonists-100289569",false,"NCT03049462","The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nCohort 1: (complete)\n\n1. Female\n2. Age 18-40 years\n3. BMI 18.00-40.0 kg\u002Fm\\^2\n4. Able to understand the research and willing to sign a written informed consent document\n\nCohort 2: (complete)\n\n1. Male\n2. Age 18-40 years\n3. BMI 18.00-40.0 kg\u002Fm\\^2\n4. Able to understand the research and willing to sign a written informed consent document\n\nCohort 3:\n\n1. Female\n2. Age 18-40 years\n3. BMI 25.0-50.0 kg\u002Fm\\^2 or BMI \\> 18.5 kg\u002Fm\\^2 with PCOS diagnosis\n4. Diagnosis of PCOS based on NIH Criteria; defined by the presence of both clinical and\u002For biochemical signs of hyperandrogenism and oligo- or chronic anovulation.\n5. 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.\n\n   a. Highly effective methods of birth control include:\n\n   i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n\n   ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable\n\n   iii. Intrauterine device\n\n   iv. Intrauterine hormone-releasing system\n\n   v. Bilateral tubal occlusion\n\n   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)\n\n   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)\n\n   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.\n6. Insulin resistance defined by either\n\n   1. HOMA-IR score \\> 5.9 OR\n   2. HOMA-IR score \\> 2.8 and \\\u003C5.9, with HDL \\\u003C51 mg\u002FdL OR\n   3. Fasting Insulin \\> 10.6 microU\u002FmL\n7. Able to understand the research and willing to sign a written informed consent document\n\nEXCLUSION CRITERIA\n\n1. Hypersensitivity and associated allergic reactions to mirabegron (or similar drug substances or components)\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)\n3. Type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%\n4. Hypertension, defined as blood pressure (Bullet)140\u002F90 mmHg, based on WHO guidelines (https:\u002F\u002Fwww.who.int\u002Fnews-room\u002Ffact-sheets\u002Fdetail\u002Fhypertension)\n5. Hypo- or hyper-thyroid disease (TSH \\>5.0, \\\u003C0.4 miU\u002FL) that is controlled for less than one year\n6. Anemia, defined by hemoglobin \\\u003C 11.3 g\u002FdL (females) or \\\u003C 13.8 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems\n7. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment\n8. A clinically significant abnormal ECG and\u002For QTc interval above normal\n9. Elevated liver enzymes with probable or diagnosed liver disease (other than fatty liver disease)\n10. 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\n11. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n12. Self-reported intolerance of cold that would prevent the individual from spending several hours in a chilled room with a cooling vest\n13. Current use of any drugs known to:\n\n    * have major drug-drug interactions with mirabegron\n    * Prolong QT interval\n    * Alter glucose metabolism or cause insulin resistance (in last six months)\n    * Treat diabetes mellitus\n    * Treat hypertension\n    * Be drugs of abuse\n14. Self-reported weight loss or weight gain \\> 5% in the preceding 6 months.\n15. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months\n16. 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.\n17. Addiction to alcohol or substances of abuse within the last 5 years\n18. Self-reported current alcohol consumption of more than 2 servings of alcohol per day\n19. Self-reported current use of nicotine and\u002For tobacco products\n20. Has participated in a clinical trial with an investigational or marketed drug within 2 months\n21. Have had previous radiation exposure (X-rays, PET scans, etc.) within the last year or anticipate radiation exposure in the upcoming year - clinical and\u002For research - that would exceed research limits\n22. Donated blood within last 2 months\n23. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n24. Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator","ALL","18 Years","40 Years",{"count":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","Background:\n\nBrown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy.\n\nObjective:\n\nTo learn more about how BAT works to burn energy.\n\nEligibility:\n\nPeople ages 18-40 with a body mass index between 18 and 40\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood, urine, and heart tests\n\nDietitian interview\n\nParticipants will have an overnight baseline visit. This includes:\n\nRepeats of screening tests\n\nExercise test\n\nScans. For one scan, a radioactive substance is injected into the arm.\n\nFSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other.\n\nMetabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature.\n\nOptional fat biopsy: A small piece of tissue is removed with a needle.\n\nParticipants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo.\n\nAll participants will have a visit after 2 weeks of the pills. They will repeat the screening tests.\n\nParticipants will have an overnight visit 2 weeks later. They will repeat the baseline tests.\n\nParticipants will keep food and medication diaries.\n\nParticipants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.",[98],"Polycystic Ovary Syndrome",[100,101,102,103],"Brown Adipose Tissue","Energy Expenditure","Energy Metabolism","Obesity","2026-05-29",{"date":106,"type":107},"2026-06-01","ACTUAL",{"date":109,"type":107},"2017-03-13",{"date":111,"type":92},"2026-09-30",{"name":47,"class":6},1]