Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes:A Registry and Diagnostic Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Diagnosed as type 2 diabetes mellitus(fulfill at least one of the followings):

• Random plasma glucose levels ≥11.1 mmol/L (twice or more on different days, or once with typical symptoms of diabetes);

• Fasting plasma glucose levels ≥ 7.0 mmol/L (twice or more on different days, or once with typical symptoms of diabetes);

• 2h plasma glucose level ≥11.1 mmol/L(twice or more on different days, or once with typical symptoms of diabetes);

• Previously diagnosed as type 2 diabetes mellitus, plasma glucose level is normal under the current diabetes treatment.

Locations
Other Locations
China
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Jinjun Chen
chjj@smu.edu.cn
8618588531001
Backup
Yali Ji
jiyl09@163.com
8615210580706
Time Frame
Start Date: 2018-05-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10000
Treatments
Type 2 Diabetes Mellitus
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov