Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes
NCT03525769 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000
Last updated 2018-05-16
Summary
This study is aimed at calculating the incidence of nonalcoholic fatty liver disease (NAFLD), non- alcoholic steatohepatitis (NASH) cirrhosis and advanced fibrosis in patients with type 2 diabetes in China, evaluating the diagnostic efficacy of FibroTouch for hepatic steatosis and fibrosis in these patients, analyzing the long-term prognosis and screening potential risk factors in patients with both type 2 diabetes and NAFLD.
This study will use FibroTouch to screen NAFLD, NASH cirrhosis and advanced fibrosis in patients with type 2 diabetes, compare the results with liver tissue biopsy to assess the clinical value of FibroTouch for the screening of NAFLD in diabetics, then investigate the clinical significance of FibroTouch in assessing the long-term prognosis of patients with diabetes and NAFLD in a prospective cohort, screen risk factors for diabetes with NAFLD and advanced fibrosis.
Conditions
- Type 2 Diabetes Mellitus
- Nonalcoholic Fatty Liver Disease (NAFLD)
Interventions
- DIAGNOSTIC_TEST
-
FibroTouch
FibroTouch is a non-invasive image-guided integrated detection system, providing an integrated detection and comprehensive evaluation program for hepatic fibrosis and hepatic steatosis. The FibroTouch is a completely non-invasive liver testing device that can obtain the following results: 1. Liver Fibrosis: quantitative results of hepatic fibrosis; 2. Fatness: quantitative result of hepatic steatosis; 3. Liver tissue morphology: detected by ultrasound imaging.
Sponsors & Collaborators
-
Nanfang Hospital, Southern Medical University
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-05
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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