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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525769
• Other study ID #: 007
• Status: Recruiting
• Start date: May 5, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen
• Phone: 8618588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Cirrhosis
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease (NAFLD)
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
China	Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular and cerebrovascular diseases	Diagnosed by cardiologists or neurologist	5 years
Other	Extrahepatic tumors	Diagnosed by oncologists	5 years
Other	Chronic kidney disease	Diagnosed by nephrologists	5 years
Primary	Death	Noticed death of patient at follow-up visit	5 years
Secondary	Liver steatosis	Liver steatosis detected by FibroTouch, or liver biopsy	5 years
Secondary	Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis	Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis detected by FibroTouch, ultrasound, CT, MRI or liver biopsy	5 years
Secondary	Hepatocellular carcinom	Hepatocellular carcinoma detected by CT, MRI or liver biopsy	5 years