The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Phase 4

Recruiting

• Conditions: Pre-diabetes; Obesity
• Interventions: Drug: Tadalafil 10 MG; Drug: Placebo; Drug: Mirabegron 50 MG

• Registration Number: NCT05051436
• Lead Sponsor: Philip Kern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2021-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tadalafil (T)	Tadalafil 10 MG	Drug will be administered for 12 weeks after baseline procedures.
Mirabegron and Tadalafil (MT)	Tadalafil 10 MG	Both drugs will be administered for 12 weeks after baseline procedures.
Placebo (P)	Placebo	-
Mirabegron (M)	Mirabegron 50 MG	Drug will be administered for 12 weeks after baseline procedures.
Mirabegron and Tadalafil (MT)	Mirabegron 50 MG	Both drugs will be administered for 12 weeks after baseline procedures.

Primary Outcome Measures

Name	Time	Method
Oral glucose tolerance test	14 weeks	Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1C	14 weeks	Participant hemoglobin A1C will be evaluated at 14 weeks.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States