TCTR20170511001已完成4 期
The effects of dapagliflozin on hepatic and visceral fat in type 2 diabetes patients with non-alcoholic fatty liver disease
The Faculty of Medicine endownment Fund0 个研究点目标入组 38 人开始时间: 2017年5月11日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
研究概览
简要总结
Dapagliflozin treatment for 12 weeks is associated with improvement in hepatic fat content, a decrease in visceral fat and bodyweight, enhanced glycemic control, and improved liver biochemistry among T2DM patients with NAFLD.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Age 18 -75 years
- •2.Patient with T2DM who are on standard medications (metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonist, alpha-glucosidase inhibitor, thiazolidinedione, in any combination) for at least 24 weeks, with stable diabetic parameters (HbA1c, FBS) and dosage
- •3.HbA1c more than 7.0% but less than 10.0%
- •4.No history of alcohol consumption of more than 10 g/d in female and 20 g/d in male in past 12 months
- •5.No other conditions that may lead to fatty liver by history, physical examination, and appropriate testing
- •6.Diagnosed NAFLD by non-contrast CT scan in past 12 months
- •7.The subject has provided written informed consent prior to admission the study
排除标准
- •1.Presence of severe acute or chronic diseases (liver, heart, renal failure), infectious or autoimmune liver diseases (positive for hepatitis B surface antigens, anti-hepatitis C virus, anti-nuclear or anti-mitochondrial antibodies)
- •2.Known history or clinical evidence of liver cirrhosis
- •3.Known allergy to SGLT2 inhibitors medication
- •4.Patient with T2DM on insulin therapy
- •5.Taken any weight loss medications within 3 months prior to admission to the study
- •6.Participants treated with vitamin E in the past immediate 6 months
- •7.eGFR by CKD-epi method < 60 ml/min/1.73m2
- •8.Pregnancy and breastfeeding
- •9.Lake of ability or willingness to give informed consent
研究者
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