NCT01997424已完成不适用
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Steatosis
研究概览
简要总结
This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination:
- Transient Elastography and Controlled Attenuation Parameter using the FibroScan
- blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years and older
- •Written informed consent
- •Diabetes mellitus type 1 or 2
排除标准
- •Patients with mental diseases
- •Pregnancy or lactation
- •Continued alcohol consumption (> 21 drinks/week for male and > 14 drinks/week for female patients)
- •Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson)
- •Hepatocellular carcinoma/ Liver metastasis
结局指标
主要结局
Steatosis
时间窗: one day
• Evaluating the presence of liver steatosis in patients with diabetes mellitus using the ultrasound-based method "Controlled Attenuation Parameter", which is integrated in the FibroScan machine and can non-invasively quantify liver steatosis (Steatosis fibrosis scores I-III \[ Designated as safety issue: No \]; Steatosis scores: 0 = \<5% I = 5-33% II = 33-66% III = \>66%)
次要结局
- Fibrosis(one day)
- Steatosis (serum)(one day)
研究者
Georg Dultz
MD
Johann Wolfgang Goethe University Hospital
研究点 (2)
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