The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics
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
- Pre-diabetes
- Obesity
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
More Details
- NCT ID
- NCT05051436
- Status
- Recruiting
- Sponsor
- Philip Kern