The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Conditions
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Pre-diabetes, Obesity

Intervention / Treatment
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* Drug: Mirabegron 50 MG
* Drug: Tadalafil 10 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirabegron (M)<br>Drug will be administered for 12 weeks after baseline procedures. | Drug: Mirabegron 50 MG<br>* Mirabegron 50 mg/day will be administered for 14 weeks.<br>|
| Experimental: Tadalafil (T)<br>Drug will be administered for 12 weeks after baseline procedures. | Drug: Tadalafil 10 MG<br>* Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.<br>|
| Experimental: Mirabegron and Tadalafil (MT)<br>Both drugs will be administered for 12 weeks after baseline procedures. | Drug: Mirabegron 50 MG<br>* Mirabegron 50 mg/day will be administered for 14 weeks.<br>Drug: Tadalafil 10 MG<br>* Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.<br>|
| Placebo Comparator: Placebo (P)<br> | Drug: Placebo<br>* Placebo will be administered for 14 weeks after baseline procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test | Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured. | Baseline | 
| Oral glucose tolerance test | Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | Participant hemoglobin A1C will be evaluated at baseline. | Baseline | 
| Hemoglobin A1C | Participant hemoglobin A1C will be evaluated at 14 weeks. | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tadalafil, Mirabegron