Mechanisms of Weight Loss With SGLT2 Inhibition
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
The purpose of this study is to investigate the effect of canagliflozin, a medication approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese.
Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.
The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •BMI 25-45 kg/m2
- •Hemoglobin A1C > 6.5% but < 9%
- •Normal renal function (GFR > 60)
排除标准
- •Type 1 diabetes
- •History of recurrent UTI or mycotic genital infections
- •Treatment with insulin or a GLP1 agent
- •Pregnant or breastfeeding
研究组 & 干预措施
Canagliflozin
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
干预措施: Canagliflozin (Drug)
Placebo
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Body Weight
时间窗: 18 weeks (duration of study)
Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit.
次要结局
- Change in Glycemic Control(18 weeks (duration of study))
- Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery(18 weeks (duration of study))
- Change in Body Composition, Measured Using DXA Scanning.(18 weeks (duration of study))
研究者
Jody Dushay
Principle Investigator
Beth Israel Deaconess Medical Center