Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
- Conditions
- ObesityWeight Loss
- Interventions
- Other: Control ArmOther: Exercise capacity VO2 maximum determinationOther: Exercise Challenge
- Registration Number
- NCT05885074
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age more than or equal to 18 years
- Body mass index more than or equal to 30 kg/m2 who have lost ≥5% of body weight within the past 6 months without taking any pharmacotherapy for weight loss
- Age less than 18 years at screening.
- Untreated systolic BP <100 or >160 mmHg at baseline, or diastolic BP <80 or >100 mmHg at baseline
- Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
- Taking pharmacotherapy indicated for weight loss, such as GLP-1 agonists or with weight loss as an adverse event
- History of Type I Diabetes
- History of lung disease
- Have any past or present illness of cardiovascular disease, including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure
- Current or past (<12 months) history of smoking
- Estimated glomerular filtration rate (GFR) < 60 ml/min/1.73 m2 (CKD-EPI equation) urine albumin creatinine ratio ≥30 mg/g
- Hepatic Transaminase (AST and ALT) levels >3x the upper limit of normal
- Significant psychiatric illness
- Anemia (men, Hct < 38%; women, Hct <36%)
- Inability to exercise on a treadmill
- Consumption of more than 2 alcoholic drinks daily
- Any contraindications to empagliflozin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin Arm Empagliflozin Arm 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. Empagliflozin Arm Exercise Challenge 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. Empagliflozin Arm Exercise capacity VO2 maximum determination 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. Placebo Arm Control Arm 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. Placebo Arm Exercise Challenge 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. Placebo Arm Exercise capacity VO2 maximum determination 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.
- Primary Outcome Measures
Name Time Method Change in Resting Energy Expenditure 12 months Change in Resting Energy Expenditure between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
- Secondary Outcome Measures
Name Time Method Change in glucagon-like peptide-1 (GLP-1) 12 months Change in glucagon-like peptide-1 (GLP-1) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in TNF-α 12 months Change in TNF-α between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in Body Weight 12 months Change in Body Weight between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in HbA1C levels 12 months Change in HbA1C levels between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in CRP 12 months Change in CRP between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in ghrelin 12 months Change in ghrelin between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in Waist Circumference 12 months Change in Waist Circumference between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in ESR 12 months Change in ESR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in peptide YY (PYY) 12 months Change in peptide YY (PYY) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in glucose-dependent insulinotropic polypeptide (GIP) 12 months Change in glucose-dependent insulinotropic polypeptide (GIP) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in Body Mass Index 12 months Change in Body Mass Index between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in lipid profile 12 months Change in Lipid profile between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in HOMA-IR 12 months Change in HOMA-IR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in IL-6 12 months Change in IL-6 between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Change in glucagon 12 months Change in glucagon between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States