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

NCT03525769 | Unknown

• 1 other identifier: 007
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Nonalcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (1)

• Death

  Noticed death of patient at follow-up visit

  5 years

Secondary Outcomes (3)

• Liver steatosis

  5 years

• Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis

  5 years

• Hepatocellular carcinom

  5 years

Other Outcomes (3)

• Cardiovascular and cerebrovascular diseases

  5 years

• Extrahepatic tumors

  5 years

• Chronic kidney disease

  5 years

Study Arms (1)

Type 2 Diabetes Mellitus

Diagnostic Test: FibroTouch

Interventions

FibroTouch DIAGNOSTIC_TEST

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.

Type 2 Diabetes Mellitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);
• h 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34993216 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

5mL peripheral blood placed in sodium citrate vacuum tube, 5mL peripheral blood serum, and 10mL random urine are collected at the baseline information and specimen collection. 10mL random urine is collected at each time follow-up. All these samples are used for screening potential indicators to evaluate prognosis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Jinjun Chen

CONTACT

8618588531001; chjj@smu.edu.cn

Yali Ji

CONTACT

8615210580706; jiyl09@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: May 5, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2018

Record last verified: 2018-04

Locations

CN (1)