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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus; Nonalcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: Diagnostic test: FibroTouch

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Yali Ji; Phone Number: 8615210580706; Email: jiyl09@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
      • Contact: Yali Ji; Phone Number: 8615210580706; Email: jiyl09@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study include 10000 type 2 diabetes patients (both inpatients and outpatients of these cooperative member hospitals). We exclude the patients with other type of diabetes, other liver diseases, pregnancy or breastfeeding,malignancy, using the drugs that would possibly cause secondary diabetes or fatty liver.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Type 2 Diabetes Mellitus

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Noticed death of patient at follow-up visit	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver steatosis	Liver steatosis detected by FibroTouch, or liver biopsy	5 years
Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis	Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis detected by FibroTouch, ultrasound, CT, MRI or liver biopsy	5 years
Hepatocellular carcinom	Hepatocellular carcinoma detected by CT, MRI or liver biopsy	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular and cerebrovascular diseases	Diagnosed by cardiologists or neurologist	5 years
Extrahepatic tumors	Diagnosed by oncologists	5 years
Chronic kidney disease	Diagnosed by nephrologists	5 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Publications and helpful links

General Publications

• Han W, Huang C, Ji Y, Zhou L, Chen J, Hou J. Alterations in the Gut Microbiota and Hepatitis-B-Virus Infection in Southern Chinese Patients With Coexisting Non-Alcoholic Fatty Liver Disease and Type-2 Diabetes Mellitus. Front Med (Lausanne). 2021 Dec 21;8:805029. doi: 10.3389/fmed.2021.805029. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 5, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Fibrosis; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No