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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK128033 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron (M) | Experimental | Drug will be administered for 12 weeks after baseline procedures. |
|
| Tadalafil (T) | Experimental | Drug will be administered for 12 weeks after baseline procedures. |
|
| Mirabegron and Tadalafil (MT) | Experimental | Both drugs will be administered for 12 weeks after baseline procedures. |
|
| Placebo (P) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron 50 MG | Drug | Mirabegron 50 mg/day will be administered for 14 weeks. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fat biopsy | Beiging of fat as measured in the lab by histochemistry. | Baseline |
| Fat biopsy | Beiging of fat as measured in the lab by histochemistry. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zach Leicht | Contact | 859-218-1397 | zachary.leicht@uky.edu | |
| Philip Kern, M.D. | Contact | 859-218-1394 | pake222@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Philip Kern, M.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
| 14 weeks |
| 14 weeks |
| Muscle biopsy | Fiber type, as measured in the lab by histochemistry. | Baseline |
| Muscle biopsy | Fiber type, as measured in the lab by histochemistry. | 14 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |