CTRI/2014/07/004725招募中不适用
The Epidemiology and Treatment of Non-Alcoholic Fatty Liver Disease In Indian Population with Diabetes And Metabolic Syndrome.
Osmania General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年5月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- a)To assess the prevalence and incidence of Non-Alcoholic Fatly Liver Disease (NAFLD) in patients with Diabetes and Metabolic Syndrome.
研究概览
简要总结
This is an observational study that will determine the prevalence and incidence of Non Alcoholic Fatty Liver Disease (NAFLD) in Patients with Diabetes and Metabolic syndrome.This study will also follow up with patients receiving treatment for NAFLD as per current guidelines and standard of care.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with Type II Diabetes Mellitus and Metabolic Syndrome a.Fasting Blood Sugar >120 mg/dL b.Metabolic Syndrome diagnosed as per NCEP- ATP III criteria.
- •2.Patients with age ≥18 years.
- •3.Patient with stable dose of diabetic medication for last three months.
- •4.Alcohol intake of < 21 units/week for men and < 14 units/week for women.
排除标准
- •1.Patient taking Thiazolidinedione’s 2.Patients with cirrhosis.
- •3.Patients with NYHA class III-IV.
- •4.Patients having neurological disease.
- •5.Patient with uncontrolled blood pressure( 3 antihypertensive medication) 6.Patients on Drugs known to induce fatty liver such as methotrexate, estrogens, tamoxifen and amiodarone.
- •7.Unable to be followed for the duration of the clinical trial 8.Inability to obtain informed consent.
结局指标
主要结局
a)To assess the prevalence and incidence of Non-Alcoholic Fatly Liver Disease (NAFLD) in patients with Diabetes and Metabolic Syndrome.
时间窗: From enrollment
b)Anthropometric measures.
时间窗: From enrollment
次要结局
- AST aspartate aminotransferase at the end of three months of treatment.(from enrollment to 3 months)
- ALT alanine aminotransferase at the end of three months of treatment.(From enrollment to 3 months)
研究者
研究点 (1)
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