IRCT20220115053717N1已完成2 期
The comparison of the Empagliflozin effect on nonalcoholic fatty liver in patients with diabetic type 2 with metformin-containing regimens
Oroumia University of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 years 至 75 years（—）
- 性别
- All
入选标准
- •Controlled type 2 Diabetes Mellitus (T2DM) with HbA1C=6.5-10
- •BMI greater than 20, with the last 3 months loss of weight below 10%
- •treatment with Metformin, 1500mg daily, at least 3 months as monotherapy
- •Statin consumption
- •Definitive diagnosis of NAFLD under the supervision of a Gastroenterology subspecialty
- •at least grade 1 of non-alcoholic fatty liver disease (NAFLD) based on ultrasonography
排除标准
- •Type 1 Diabetes Mellitus (T1DM)
- •Treated with other diabetes medications except for metformin at baseline
- •History of pancreatitis or pancreas related diseases
- •At the beginning of the study ALT more than twice normal upper limits
- •eGFR lower than 45 ml/min
- •Decompensated or untreated Heart Failure (functional class 3 or 4)
- •Other liver diseases include autoimmune hepatitis and viral hepatitis
- •Alcohol consumption more than 140 cc for women and 250 cc for men per week
- •A pregnant woman or someone who is planning a pregnancy
- •breastfeeding
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