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Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (REE), which may be a probable mechanism for this lack of WLM. Most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in REE which prevents WLM. Therefore, techniques that increase REE may promote WLM in these individuals. Pre-clinical studies for Empagliflozin - Sodium-glucose Cotransporter-2 (SGLT2) inhibitor have shown an increase in REE. Thus, in addition to reducing the cardiovascular risk, SGLT2 inhibitor may promote WLM by increasing REE. This study aims to promote WLM in obese individuals by increasing the REE using SGLT2 inhibitor therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin Arm | Experimental | Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take empagliflozin 25mg/day orally for 12 months. |
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| Placebo Arm | Placebo Comparator | Investigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take a placebo pill orally once a day for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin Arm | Drug | The subject will be randomized, in a double-blind manner to Empagliflozin 25mg once daily for a period of 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Energy Expenditure | Change in Resting Energy Expenditure between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in Body Weight between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in Body Mass Index | Change in Body Mass Index between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pankaj Arora, MD, FAHA | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Control Arm | Other | The subject will be randomized, in a double-blind manner to receive placebo once daily for a period of 12 months |
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| Exercise capacity VO2 maximum determination | Other | Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol and will also undergo a DEXA scan to determine the body mass. |
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| Exercise Challenge | Other | Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill and will also undergo a resting energy expenditure test. |
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| 12 months |
| Change in Waist Circumference | Change in Waist Circumference between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in HbA1C levels | Change in HbA1C levels between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in lipid profile | Change in Lipid profile between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in HOMA-IR | Change in HOMA-IR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in ESR | Change in ESR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in CRP | Change in CRP between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in IL-6 | Change in IL-6 between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in TNF-α | Change in TNF-α between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in glucagon-like peptide-1 (GLP-1) | Change in glucagon-like peptide-1 (GLP-1) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in peptide YY (PYY) | Change in peptide YY (PYY) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in ghrelin | Change in ghrelin between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in glucose-dependent insulinotropic polypeptide (GIP) | Change in glucose-dependent insulinotropic polypeptide (GIP) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| Change in glucagon | Change in glucagon between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention | 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |