[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05051436":3,"trial-entities:NCT05051436":111,"trial-summary:NCT05051436":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":48,"secondary_outcomes":56,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":80,"locations":83,"central_contacts":102,"overall_officials":107,"references":109,"see_also_links":110},"NCT05051436","55665","The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics","RECRUITING","2026-08","2026-02","2026-02-03","2021-12-13","Philip Kern","OTHER",false,"The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.",null,[18,19],"Pre-diabetes","Obesity",[21,22],"Tadalafil","Mirabegron","INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},96,"ESTIMATED",[31,38,43],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Mirabegron 50 MG","Mirabegron 50 mg\u002Fday will be administered for 14 weeks.",[36,37],"Mirabegron (M)","Mirabegron and Tadalafil (MT)",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Tadalafil 10 MG","Tadalafil 10 mg\u002Fday will be administered for 14 weeks after baseline procedures.",[37,42],"Tadalafil (T)",{"type":32,"name":44,"description":45,"armGroupLabels":46},"Placebo","Placebo will be administered for 14 weeks after baseline procedures.",[47],"Placebo (P)",[49,53],{"measure":50,"description":51,"timeFrame":52},"Oral glucose tolerance test","Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.","Baseline",{"measure":50,"description":54,"timeFrame":55},"Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.","14 weeks",[57,60],{"measure":58,"description":59,"timeFrame":52},"Hemoglobin A1C","Participant hemoglobin A1C will be evaluated at baseline.",{"measure":58,"description":61,"timeFrame":55},"Participant hemoglobin A1C will be evaluated at 14 weeks.","ALL","35 Years","65 Years",true,{"inclusion":67,"exclusion":70,"raw_text":79},[68,69],"Hemoglobin A1C between 5.7 and 6.4","Body mass index between 27 and 45",[71,72,73,74,75,76,77,78],"Diabetes","Chronic use of any antidiabetic medications","Any unstable medical condition","Use of steroids or daily use of NSAIDS","History of chronic inflammatory conditions","Use of anticoagulants","Contraindications to the use of mirabegron or tadalafil","Any condition deemed risky by the study physician","Inclusion Criteria:\n\n* Hemoglobin A1C between 5.7 and 6.4\n* Body mass index between 27 and 45\n\nExclusion Criteria:\n\n* Diabetes\n* Chronic use of any antidiabetic medications\n* Any unstable medical condition\n* Use of steroids or daily use of NSAIDS\n* History of chronic inflammatory conditions\n* Use of anticoagulants\n* Contraindications to the use of mirabegron or tadalafil\n* Any condition deemed risky by the study physician",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":99},"University of Kentucky","Lexington","Kentucky","40536","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Zach Leicht","CONTACT","859-218-1397","zachary.leicht@uky.edu",{"name":97,"role":98},"Philip Kern, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},37.98869,-84.47772,[103,104],{"name":92,"role":93,"phone":94,"email":95},{"name":97,"role":93,"phone":105,"email":106},"859-218-1394","pake222@uky.edu",[108],{"name":97,"affiliation":85,"role":98},[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[19,113],"Prediabetes",[],{"nct_id":4,"found":65,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study planning to enroll 96 participants. Participants will receive either mirabegron, tadalafil, or a placebo.","completed","Mirabegron and Tadalafil for Prediabetes","This study is looking at how two medications, mirabegron and tadalafil, might affect blood sugar control in people with prediabetes and obesity. Researchers want to see if mirabegron alone, or in combination with tadalafil, can improve how your body handles sugar. You might be able to join if you are between 35 and 65 years old, have a specific A1C level (a measure of average blood sugar) between 5.7 and 6.4, and a body mass index (BMI) between 27 and 45. The study will compare these medications to a placebo (an inactive pill) over 14 weeks. The main goal is to see if these treatments improve your oral glucose tolerance test results.","Your glucose tolerance will be measured at 14 weeks, which appears to be the end of the study period.",112,"You would take a study drug (mirabegron, tadalafil, or placebo) for 14 weeks. Your oral glucose tolerance will be measured at the beginning and end of this period.","Not stated in the trial record.",[44],"v2"]