[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413672":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":51,"centralContacts":55,"locations":64,"responsibleParty":81,"collaborators":85,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":35,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":35,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":66,"whyStopped":35,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants in the group will receive placebo.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Mirabegron","EXPERIMENTAL","Participants in this group will receive Mirabegron for 16 weeks.",[19],"Drug: Mirabegron",{"label":21,"type":16,"description":22,"interventionNames":23},"Sub-Study: Mirabegron and the acute response to food","This sub-study will involve the recruiting of the same subjects who are eligible for this study as described above. Subjects will report to the CCTS fasting on 3 separate days. On each visit, the subject will have 5 blood draws and each blood draw will be about 8 ml, for a total of 40 ml of blood at each visit. Visit 1 will involve the participant consuming a standardized meal. At visit 2, participants will take 50mg of Mirabegron. And visit 3 will involve the participant consuming the same meal as visit 1 and also taking 50 mg of mirabegron.",[24],"Drug: Mirabegron 50 MG",{"label":26,"type":16,"description":27,"interventionNames":28},"Sub-Study: Mirabegron dosing and Oral Glucose Tolerance Tests (Optional)","Studies have found that larger doses of mirabegron do not elicit the same improvements in insulin sensitivity. Therefore, we aim to perform a dose-response study to gain an improved understanding of mirabegron dosing and changes in insulin sensitivity.\n\nThis sub-study will have 4 total visits. visit 1 is a baseline oral glucose tolerance test. At the end of visit 1, participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks leading up to visit 2. Visit 2 will also be a standard oral glucose tolerance test. At the end of visit 2, participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks leading up to visit 3. Visit 3 will also be a standard oral glucose tolerance test. At the end of visit 3, participants will be given 6 weeks of mirabegron (10 mg) and take 1 pill once per day for 4-6 weeks. Visit 4 will be the final visit and will also be a standard oral glucose tolerance test.",[29],"Drug: Mirabegron 100 mg",[31,36,41,46],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Participants will take one pill (placebo) daily for the first week and two pills daily for the remaining 15 weeks.",[9],null,{"type":32,"name":15,"description":37,"armGroupLabels":38,"otherNames":39},"Participants will take one pill (50mg Mirabegron) daily for the first week. For week two, participants will take two pills (50mg and 25mg Mirabegron). Unless there are side effects, for the remaining 14 weeks participants will take two pills (50mg each) daily.",[15],[40],"Myrbetriq",{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Mirabegron 50 MG","Participants will take one pill (50mg Mirabegron) daily between visit 2 and visit 3",[21],[40],{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Mirabegron 100 mg","participants will be given 6 weeks of mirabegron (25 mg) and will take 1 pill once per day for 4-6 weeks. Next participants will be given 6 weeks of mirabegron (50 mg) and take 1 pill once per day for 4-6 weeks. Last participants will be given 6 weeks of mirabegron (100 mg) and take 1 pill once per day for 4-6 weeks.",[26],[40],[52],{"name":53,"affiliation":5,"role":54},"Philip Kern, MD","PRINCIPAL_INVESTIGATOR",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":35,"email":60},"Zach Leicht","CONTACT","859-218-1397","zachary.leicht@uky.edu",{"name":53,"role":58,"phone":62,"phoneExt":35,"email":63},"859-218-1394","pake222@uky.edu",[65],{"facility":5,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Lexington","Kentucky","40536","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-84.47772,37.98869,{"lat":76,"lon":75},[79,80],{"name":57,"role":58,"phone":59,"phoneExt":35,"email":60},{"name":53,"role":54,"phone":35,"phoneExt":35,"email":35},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Philip Kern","Professor",[86],{"name":87,"class":88},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100413672","phase-2-mechanisms-for-activation-of-beige-adipose-tissue-in-humans-100413672",false,"NCT04666636","Mechanisms for Activation of Beige Adipose Tissue in Humans","Inclusion Criteria:\n\n* BMI 27-45\n* prediabetes (A1c 5.7-6.4)\n* impaired fasting glucose or impaired glucose tolerance\n\nExclusion Criteria:\n\n* diabetes\n* chronic use of anti-diabetic medication\n* acute or chronic inflammatory condition\n* unstable medical condition\n* cancer\n* renal insufficiency\n* any contraindication for Mirabegron\n* BMI \\>45",true,"ALL","35 Years","65 Years",{"count":100,"type":101},65,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients",[107],"PreDiabetes",[109,110,111,112,113,114,115,116],"beige","adipose","glucose","fat","BAT","diabetes","metabolism","DEXA","2026-02-02",{"date":119,"type":120},"2026-02-03","ACTUAL",{"date":122,"type":120},"2020-12-07",{"date":124,"type":101},"2026-12-01",{"name":83,"class":6},1]