Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Resting Energy Expenditure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Empagliflozin Arm (Drug)
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.
干预措施: Exercise capacity VO2 maximum determination (Other)
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.
干预措施: Exercise Challenge (Other)
Placebo 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.
干预措施: Control Arm (Other)
Placebo 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.
干预措施: Exercise capacity VO2 maximum determination (Other)
Placebo 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.
干预措施: Exercise Challenge (Other)
结局指标
主要结局
Change in Resting Energy Expenditure
时间窗: 12 months
Change in Resting Energy Expenditure between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention
次要结局
- Change in glucagon-like peptide-1 (GLP-1)(12 months)
- Change in TNF-α(12 months)
- Change in Body Weight(12 months)
- Change in HbA1C levels(12 months)
- Change in CRP(12 months)
- Change in ghrelin(12 months)
- Change in Waist Circumference(12 months)
- Change in ESR(12 months)
- Change in peptide YY (PYY)(12 months)
- Change in glucose-dependent insulinotropic polypeptide (GIP)(12 months)
- Change in Body Mass Index(12 months)
- Change in lipid profile(12 months)
- Change in HOMA-IR(12 months)
- Change in IL-6(12 months)
- Change in glucagon(12 months)
研究者
Pankaj Arora, MD
Associate Professor
University of Alabama at Birmingham