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| ID | Type | Description | Link |
|---|---|---|---|
| 2107866 | Other Identifier | Local IRB |
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| Name | Class |
|---|---|
| University of Missouri-Columbia | OTHER |
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The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.
The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental | 12 week treatment with 10mg empagliflozin daily |
|
| Placebo | Placebo Comparator | 12 week treatment with 10mg placebo daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | 12 week treatment with 10mg empagliflozin daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid-femoral Pulse Wave Velocity (cfPWV) | cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points. | baseline (t0), week 4, week 8, week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaume Padilla Parellada, PhD | Contact | (573) 814-6552 | jaume.padillaparellada@va.gov | |
| Katherine M Burr | Contact | (573) 814-6550 | Katherine.Burr@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jaume Padilla Parellada, PhD | Harry S. Truman Memorial, Columbia, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harry S. Truman Memorial, Columbia, MO | Recruiting | Columbia | Missouri | 65201-5275 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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placebo-controlled trial
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double-blinded
| Placebo |
| Drug |
12 week treatment with 10mg placebo daily |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |