IRCT20190122042450N3已完成2 期
Comparison of the effect of empagliflozin and pioglitazone and placebo on liver steatosis change in fibroscan in diabetic patients with non-alcoholic fatty liver disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
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 65 years（—）
- 性别
- All
入选标准
- •Body mass index less than 40
- •Alcohol daily consumption less than 20 g in women and less than 30 g in men, for at least 3 consecutive months over 5 years ago
- •Hemoglobin A1c 7-10 percent
- •Alanin aminotransferase more than 45 in men and more than 30 in women
- •Creatinin less than 1.5 in men and less than 1.4 in women and glomerular filtration rate more than 45
- •Controlled atenuated parameter more than 230 in fibroscan or fatty liver grade equal and more than 2 in liver sonography
- •Signature of consent form
排除标准
- •Pregnancy, breast feeding
- •Heart failure (class II to IV)
- •History of cardiovascular disease in 3 months ago
- •History of cancer in 2 years ago
- •History of cirrhosis Abnormal TSH (uncontrolled yper or hypothyroidism)
- •Autoimmune hepatitis (abnormal ANA and ASMA)
- •Hepatitis C (positive HCV Ab)
- •Hepatitis B (positive HBS Ag)
- •Consumption of NSAIDs, Amiodarone, Tamoxifen, Fibrate, statin, Zinc, Selenium and vitamin C or other antioxidant drugs, Empagliflozin, Metformin, Pioglitazone, Vitamin E and other fatty liver drugs.
- •Diabetes type 1 or secondary diabetes
- •Consumption of corticosteroid for 14 days over 2 months ago
- •biliary obstruction in liver and gallbladder sonography
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