Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes

Recruiting

• Conditions: Type 2 Diabetes Mellitus; Nonalcoholic Fatty Liver Disease (NAFLD)
• Interventions: Diagnostic Test: FibroTouch

• Registration Number: NCT03525769
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

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 Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-03
• Last Update Submitted: 2018-05-03
• Study Start: 2018-05-05
• Study First Posted: 2018-05-16
• Last Update Posted: 2018-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

1. Random plasma glucose levels ≥11.1 mmol/L (twice or more on different days, or once with typical symptoms of diabetes);
2. Fasting plasma glucose levels ≥ 7.0 mmol/L (twice or more on different days, or once with typical symptoms of diabetes);
3. 2h plasma glucose level ≥11.1 mmol/L(twice or more on different days, or once with typical symptoms of diabetes);
4. Previously diagnosed as type 2 diabetes mellitus, plasma glucose level is normal under the current diabetes treatment.

Exclusion Criteria

• Type 1 diabetes or other types of diabetes;
• Acute or chronic infection;
• Other diseases that cause secondary diabetes: such as pancreatic disease, Cushing's syndrome, acromegaly, glucagonoma, pheochromocytoma, hyperthyroidism, somatostatin, aldosteronoma, etc.;
• Using drugs that cause secondary diabetes (glucocorticoid, thyroid hormone, phenytoin, alpha-interferon, etc.)
• Hepatitis B surface antigen positive (HBsAg+), or hepatitis C antibody positive (Anti-HCV+), or other liver diseases such as alcoholic liver disease;
• Alcohol intake ≥140g/week for men (or ≥70 g/week for women);
• Diagnosed with HCC or other malignancy (in accordance with the appropriate diagnostic criteria);
• Drugs secondary to fatty liver (tamoxifen, amiodarone, valproate, methotrexate, glucocorticoids, etc.).
• During pregnancy or breastfeeding;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Mellitus	FibroTouch	-

Primary Outcome Measures

Name	Time	Method
Death	5 years	Noticed death of patient at follow-up visit

Secondary Outcome Measures

Name	Time	Method
Liver steatosis	5 years	Liver steatosis detected by FibroTouch, or liver biopsy
Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis	5 years	Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis detected by FibroTouch, ultrasound, CT, MRI or liver biopsy
Hepatocellular carcinom	5 years	Hepatocellular carcinoma detected by CT, MRI or liver biopsy

Trial Locations

Locations (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China