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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · May 3, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how well a device called FibroTouch can help identify advanced liver conditions in people who have type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). Researchers want to find out how common these liver issues are among diabetes patients in China and understand the long-term health risks associated with them. Participants will have their liver health tested using FibroTouch, and the results will be compared to more traditional liver tests (like biopsies) to see how effective this new method is.

To be eligible for this study, participants must be diagnosed with type 2 diabetes and meet certain blood sugar level criteria. This trial is not open to individuals with type 1 diabetes, other specific health conditions, or those who are pregnant or breastfeeding. If you join the study, you can expect to undergo non-invasive screenings and help researchers learn more about the connection between diabetes and liver health, which could lead to better care for patients in the future.

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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;