Clinical trial

Clinical Course and Biomarkers Associated With Nonalcoholic Fatty Liver Disease (NAFLD) in Chinese Patients With Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07662356

Recruiting nowNot applicableObservational

What this study is about

Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in many parts of the world. NAFLD can progress to nonalcoholic steatohepatitis (NASH) and result in cirrhosis and liver cancer. Despite NAFLD is common, there are a lot of knowledge gaps about this common disease including the progression from NAFLD to NASH and from fibrosis to cirrhosis, efficacious treatment strategies, etc. In this study, we aim to investigate the clinical course and biomarkers associated with NAFLD in a group of obese patients with or without known history of NAFLD at baseline undergoing laparoscopic bariatric surgery. During laparoscopic surgery, subjects consented to participate will have liver biopsies performed under direct vision and sent for histological analysis and scoring. The patients will undergo comprehensive clinical and biochemical assessment before and after the surgical procedures. The prevalence of NAFLD and clinical course of this group of patients with obesity will be assessed using histology as the gold standard. Clinical characteristics and biomarkers associated with NAFLD will be identified.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionNonalcoholic Fatty Liver Disease (NAFLD)

Full registry criteria

Inclusion Criteria: * Age 18 years or above * Chinese ethnicity * Patient undergoing obesity surgery at The Prince of Wales Hospital Exclusion Criteria: * Endocrine causes of obesity * Active uncontrolled psychiatric illness * Active substance abuse * Alcohol intake exceeding 30 grams per day in males or 20 grams per day in females * Presence of other co-existing liver disease, as evidenced by known history of positive viral hepatitis serology * History of decompensated liver disease * Unlikely to comply with management protocol * Failure to give consent

Treatments and study arms

Case Group

Other

Obese cases with NAFLD

Primary outcomes

Prevalence of NAFLD and NASH at baseline, based on histological assessmentBaseline

Histological scoring of NAFLD will be based on the Brunt's system.20 In brief, liver steatosis is graded from 0 to 3, necroinflammation graded from 0 to 3, and fibrosis staged from 0 to 4. Nonalcoholic steatohepatitis (NASH) is defined as necroinflammatory grade 2/3 and/or fibrosis stage ≥1.

The clinical course predicting NAFLD and NASH in this cohort1 year

Including fibroscan and liver enzymes

Correlation between serum alanine aminotransferase and histological severity1 year

Biomarkers predicting NAFLD and NASH in this cohort1 year

* R/LFT, AST, GGT, fasting glucose, total cholesterol, HDL-C, LDL-C, triglycerides, HbA1c * Fasting insulin and C-peptide * HBsAg, anti-HCV * Thyroid function test and overnight dexamethasone suppression test (if clinically indicated) * CXR * ECG * Ultrasound abdomen * Other tests as clinically indicated * Clotted blood and EDTA blood for future biochemical and genetic studies

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital🇭🇰 Hong Kong, New Territories, Hong Kong

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Alice Pik Shan Kong, MDContact

Email · Call +852 3505 2648