The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Philip Kern
Study ID
NCT05051436
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Mirabegron 50 MG — DRUG
    Mirabegron 50 mg/day will be administered for 14 weeks.
  • Tadalafil 10 MG — DRUG
    Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
  • Placebo — DRUG
    Placebo will be administered for 14 weeks after baseline procedures.

Study Details

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.

Key Dates

Start date
Dec 13, 2021
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Oral glucose tolerance test [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Zach Leicht
[email protected]
859-218-1397
Philip Kern, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lexington, KY

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Kentucky· Lexington, KY

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