TCTR20190118008已完成3 期
Effect of Canagliflozin on liver steatosis in obese non diabetic patients with non-alcoholic fatty liver disease: A double blind randomized controlled trial
Ratchadaphiseksomphot Endowment Fund0 个研究点目标入组 82 人开始时间: 2019年1月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
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
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Age 18-80 years old
- •2. BMI 25-35 kg/m2
- •3. Evidence of hepatic steatosis by imaging (ultrasound, CT or MRI)
- •4. CAP values above 200 dB/m
排除标准
- •1.Evidence of liver cirrhosis by ultrasound or Fibroscan (LSM > 12 kPa)
- •2.Estimated GFR < 45 ml/min/1.73m2
- •3.Type2 diabetes mellitus
- •4.SBP<90 mmHg
- •5.Male patients with alcohol consumption >30g/day and female patients with alcohol consumption >20g/day using AUDIT, Skinner alcohol question
- •6.Chronic B viral hepatitis or evidence of previous infection, chronic C viral hepatitis, autoimmune liver disease, hemochromatosis, Wilson's disease and other liver diseases
- •7.Exposure to drug induced steatohepatitis with in the previous 6 months: Aspirin, Amiodarone, Chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase, irinotecan), Cocaine, Glucocorticoids, Methotrexate, Nucleoside reverse transcriptase inhibitors (NRTI), Tetracycline (Intravenous administration of high doses), Total parenteral nutrition, and Valproic acid
- •8.Weight gain or loss ≥5 kg in last 6 months
- •9.Current or previous use following drugs within the past 6 months: SGLT2 inhibitor, pioglitazone, vitamin E, and liraglutide
- •10.Patient underwent bariatric surgery within 5 years
- •11.History of diabetic ketoacidosis
- •12.History of peripheral arterial disease or lower limb amputation
- •13.History of recurrent urinary tract infection
- •14.History of fungal infection in genital area
- •15.Documented genitourinary tract structural abnormality
- •16.Pregnant women or nursing mothers
- •17.Patients do not provide a written informed consent.
研究者
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