NCT03060694已完成不适用
Screening Inpatients With Type 2 Diabetes for Nonalcoholic Fatty Liver Disease Using Controlled Attenuation Parameter and Liver Stiffness Measurements
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- controlled attenuation parameter; liver stiffness measure
研究概览
简要总结
The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in non-diabetic patients.
详细描述
- Patient recruitment: eligible patients in the department of endocrinology and department of gastroenterology are encouraged to participate in this study.
- Non-diabetic patients admitted to the department of gastroenterology for other gastroenterological diseases. If available, these patients' data will be collected as control groups. Each diabetic patient is matched with a non-diabetic patient by factors of age, gender and BMI.
- Hepatic steatosis and fibrosis are diagnosed via controlled attenuation parameter (CAP) and liver stiffness measurement by FibroScan ®, respectively. According to the meta-analysis of individual patient data published recently, the CAP in dB/m will be adjusted by deducting 10dB/m from the CAP value for NAFLD/NASH patients, 10dB/m for diabetes patients and deducting/adding 4.4dB/m for each unit of BMI above/below 25kg/m2 over the range of 20-30kg/m2.
- Regular laboratory tests are performed, including complete blood counts, liver function, renal function, coagulation function, glycosylated hemoglobin, lipid metabolism, urine albumin/creatinine ratio, 24-hour urine albumin.
- Anthropometric data consists of height, weight, body mass index (the weight in kilograms divided by the square of the height in meters) and waist circumference.
- The diabetic duration, diabetic complications, the grading of hypertension, and the history of anti-diabetic drugs are gathered from medical records.
- The data are collected via EpiData software. They are input into computer twice by a single researcher to avoid typing errors.
- Site monitoring and auditing: As a project for postgraduate thesis, this study is monitored and audited by the school of postgraduate. The research records will be checked in December, 2016, as a mid-term inspection
- Statistical analysis plan: data are summarized and presented using appropriate descriptive statistics. The normality of continuous variables is assessed by skewness statistic and graphically by normal probability plot. Patients characteristics between those with and without diabetes, and in diabetes group, between those with and without elevated CAP are compared using independent t test, Chi-square, or Fisher's exact tests as appropriate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •≥18 years
- •type 2 diabetics
排除标准
- •malignancy;
- •severe cardiovascular complications;
- •any history of chronic hepatitis (hepatitis B or C virus infection, autoimmune hepatitis, Wilson's disease, hemachromatosis);
- •secondary causes of fatty liver ( glucocorticoids, amiodarone, tamoxifen);
- •alcohol consuming (20grams per day for male, and 10 grams per day for female);
- •any hints of type 1 diabetes ( ketoacidosis, ketonuria, using insulin within 1 year after diagnosis)
结局指标
主要结局
controlled attenuation parameter; liver stiffness measure
时间窗: one day
次要结局
未报告次要终点
研究者
研究点 (1)
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