Clinical trial NCT03525769: Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes
Official title: Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes：A Registry and Diagnostic Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Nonalcoholic Fatty Liver Disease (NAFLD)
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Death
timeFrame: 5 years
Secondary outcomes:
measure: Liver steatosis
timeFrame: 5 years
measure: Advanced fibrosis, compensated cirrhosis, decompensated cirrhosis
timeFrame: 5 years
measure: Hepatocellular carcinom
timeFrame: 5 years
Other outcomes:
measure: Cardiovascular and cerebrovascular diseases
timeFrame: 5 years
measure: Extrahepatic tumors
timeFrame: 5 years
measure: Chronic kidney disease
timeFrame: 5 years
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
citation: 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.