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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03060694
Enrollment
58
Registered
2017-02-23
Start date
2016-09-30
Completion date
2017-05-31
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2

Brief summary

The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in non-diabetic patients.

Detailed description

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.

Interventions

OTHERdiabetes

1. a history of diabetes and using anti-diabetic medicines. 2. fasting serum glucose level greater than 7.1mmol/L, or glycosylated hemoglobin percentage greater than 6.5%.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
controlled attenuation parameter; liver stiffness measureone day

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026