Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT03525769
Status:
RECRUITING
Last Update Posted:
2018-05-16
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes：A Registry and Diagnostic Cohort Study
Status:
RECRUITING
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
This study is a multicenter, prospective, observational cohort study. We plan to include 10,000 patients with type 2 diabetes, and use FibroTouch to screen for NAFLD, NASH cirrhosis and advanced fibrosis in these patients. In the group of patients who experienced liver biopsies in clinical practice, we compare their FibroTouch results and liver biopsy pathology results, to evaluate the clinical value of FibroTouch in diagnosing NAFLD, NASH cirrhosis and advanced fibrosis in diabetics. We will calculate the incidence and analyze risk factors of NAFLD, NASH cirrhosis and advanced fibrosis in patients with type 2 diabetes. All patients will be followed-up for 5 years (once a year for patients without cirrhosis, twice a year for patients with cirrhosis), to observed endpoint events. This study will explore the significance of FibroTouch result and other clinical indicators in assessing the long-term prognosis of diabetic patients with NAFLD.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: