The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: t
View:
• Hemoglobin A1C between 5.7 and 6.4
• Body mass index between 27 and 45
Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Douglas Long, M.S.
delong2@uky.edu
859-323-5438
Backup
Philip Kern, M.D.
pake222@uky.edu
859-218-1394
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 96
Treatments
Experimental: Mirabegron (M)
Drug will be administered for 12 weeks after baseline procedures.
Experimental: Tadalafil (T)
Drug will be administered for 12 weeks after baseline procedures.
Experimental: Mirabegron and Tadalafil (MT)
Both drugs will be administered for 12 weeks after baseline procedures.
Placebo_comparator: Placebo (P)
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Philip Kern