Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
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.
1. Patient recruitment: eligible patients in the department of endocrinology and department
of gastroenterology are encouraged to participate in this study.
2. 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.
3. 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.
4. 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.
5. 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.
6. The diabetic duration, diabetic complications, the grading of hypertension, and the
history of anti-diabetic drugs are gathered from medical records.
7. The data are collected via EpiData software. They are input into computer twice by a
single researcher to avoid typing errors.
8. 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
9. 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.
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