Screening for liver fibrosis in diabetes patients using FibroTouch
Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes：A Registry and Diagnostic Cohort Study
This study is testing if a new screening tool called FibroTouch can help find liver problems in people with type 2 diabetes in China.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03525769 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of nonalcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) cirrhosis, and advanced fibrosis in patients with type 2 diabetes in China. It will utilize FibroTouch to screen these conditions and compare the results with liver biopsies to evaluate the diagnostic accuracy of FibroTouch. The study will include 10,000 patients and will follow them for five years to analyze long-term outcomes and identify potential risk factors associated with NAFLD and diabetes.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with type 2 diabetes mellitus.
Not a fit: Patients with type 1 diabetes or other secondary causes of diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection and management of liver complications in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using non-invasive methods for liver disease screening, but this specific approach with FibroTouch is novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Guangzhou, Guangdong
- Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jinjun Chen
- Email: chjj@smu.edu.cn
- Phone: 8618588531001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.