Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 35 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Hemoglobin A1C between 5.7 and 6.4 - Body mass index between 27 and 45

Exclusion Criteria

  • 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mirabegron (M) 		Drug will be administered for 12 weeks after baseline procedures.
  • Drug: Mirabegron 50 MG
    Mirabegron 50 mg/day will be administered for 14 weeks.
Experimental
Tadalafil (T) 		Drug will be administered for 12 weeks after baseline procedures.
  • Drug: Tadalafil 10 MG
    Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Experimental
Mirabegron and Tadalafil (MT) 		Both drugs will be administered for 12 weeks after baseline procedures.
  • Drug: Mirabegron 50 MG
    Mirabegron 50 mg/day will be administered for 14 weeks.
  • Drug: Tadalafil 10 MG
    Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
Placebo Comparator
Placebo (P)
  • Drug: Placebo
    Placebo will be administered for 14 weeks after baseline procedures.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Douglas Long
859-323-5438
delong2@uky.edu

More Details

NCT ID
NCT05051436
Status
Recruiting
Sponsor
Philip Kern

Study Contact

Douglas Long, M.S.
859-323-5438
delong2@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.