Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes: A 12-week Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Liver Fat
研究概览
简要总结
Fatty liver disease is an increasingly recognized health problem in patients with type 2 diabetes mellitus (T2DM). Sodium glucose co-transporter type 2 (SGLT-2) inhibitors are a new class of anti-diabetic agents that cause weight loss by inducing glycosuria. The effect of SGLT-2 inhibitors on liver fat content is not evaluated. Empagliflozin is an orally active, selective inhibitor of SGLT-2. We hypothesized that Empagliflozin, when added to standard care for T2DM, would improve fatty liver disease. Therefore, the present study is planned to evaluate the effect of Empagliflozin on the liver fat content.
详细描述
Fatty liver disease is an increasingly recognized health problem in patients with type 2 diabetes mellitus (T2DM). Sodium glucose co-transporter type 2 (SGLT-2) inhibitors are a new class of anti-diabetic agents that cause weight loss by inducing glycosuria. The effect of SGLT-2 inhibitors on liver fat content is not evaluated. Empagliflozin is an orally active, selective inhibitor of SGLT-2. We hypothesized that Empagliflozin, when added to standard care for T2DM, would improve fatty liver disease. Therefore, the present study is planned to evaluate the effect of Empagliflozin on the liver fat content.
Review of literature
Empagliflozin is a selective SGLT-2 inhibitor, recently approved by the U.S. FDA for use in patients with T2DM. Empagliflozin in patients with type 2 diabetes provided sustained glycemic control and weight loss over 90 weeks and was generally well tolerated (1). Another study demonstrated that Empagliflozin in patients with T2DM resulted in reductions in HbA1c and fasting plasma glucose (FPG), and reductions in body weight compared with placebo. Empagliflozin was well tolerated with a favorable safety profile (2). Some congeners of this class of molecules have been seen to reduce liver fat content in rat models. However, the effect of this drug on liver fat content in humans has not been evaluated.
Research question
Does Empagliflozin reduce liver fat content in patients with T2DM and fatty liver disease?
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM of age 40 years and above
- •Fatty liver disease (grade I or more on USG)
- •Glycated A1C more than 7.0% but less than 10.0%
- •Patient on standard care of T2DM (metformin, sulfonylureas, DPP-4 inhibitors or insulin, in any combination).
排除标准
- •Serum creatinine more than 1.5 mg/dL
- •Participants treated with pioglitazone or vitamin E in the immediate past 6 months
- •Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).
研究组 & 干预措施
Empagliflozin dose group
Patient Receive Standard of Care with Empagliflozen
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Change in Liver Fat
时间窗: 3 Months
To evaluate the change in liver fat content at baseline and 3 Months
次要结局
- Pancreatic fat content(3 Months)
- visceral fat(3 Months)
- subcutaneous fat(3 Months)
研究者
Dr Mohammad Shafi Kuchay
Endocrinologist
Medanta, The Medicity, India