Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Screening Inpatients With Type 2 Diabetes for Nonalcoholic Fatty Liver Disease Using Controlled Attenuation Parameter and Liver Stiffness Measurements
The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in non-diabetic patients.
研究概览
详细说明
- 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.
研究类型
观察性的
注册 (实际的)
58
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai、中国
- Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
inpatients in the department of endocrinology in Xinhua Hospital
描述
Inclusion Criteria:
- ≥18 years
- type 2 diabetics
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Diabetes group
Patients in this group are recruited from both departments of endocrinology and gastroenterology.
The diagnosis of diabetes is confirmed by medical history, using anti-diabetic medicines or laboratory tests.
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Non-diabetes group
Patients in this group are recruited from department of gastroenterology.
The exclusion of diabetes is confirmed by medical history or laboratory tests.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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controlled attenuation parameter; liver stiffness measure
大体时间：one day
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one day
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zhengjie Xu, MD、Xinhua Hospital, Shanghai Jiaotong Univerisity School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kwok R, Choi KC, Wong GL, Zhang Y, Chan HL, Luk AO, Shu SS, Chan AW, Yeung MW, Chan JC, Kong AP, Wong VW. Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. Gut. 2016 Aug;65(8):1359-68. doi: 10.1136/gutjnl-2015-309265. Epub 2015 Apr 14.
- Karlas T, Petroff D, Sasso M, Fan JG, Mi YQ, de Ledinghen V, Kumar M, Lupsor-Platon M, Han KH, Cardoso AC, Ferraioli G, Chan WK, Wong VW, Myers RP, Chayama K, Friedrich-Rust M, Beaugrand M, Shen F, Hiriart JB, Sarin SK, Badea R, Jung KS, Marcellin P, Filice C, Mahadeva S, Wong GL, Crotty P, Masaki K, Bojunga J, Bedossa P, Keim V, Wiegand J. Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol. 2017 May;66(5):1022-1030. doi: 10.1016/j.jhep.2016.12.022. Epub 2016 Dec 28.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (实际的)
2017年2月1日
研究完成 (实际的)
2017年5月1日
研究注册日期
首次提交
2017年2月19日
首先提交符合 QC 标准的
2017年2月19日
首次发布 (实际的)
2017年2月23日
研究记录更新
最后更新发布 (实际的)
2018年5月11日
上次提交的符合 QC 标准的更新
2018年5月6日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.