About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or above
Chinese ethnicity
Patient undergoing obesity surgery at The Prince of Wales Hospital
Disqualifiers
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
Trial population
Patient undergoing obesity surgery at The Prince of Wales Hospital。
Trial design
Case-control
Prospective
Treatments tested in this trial
Case Group
Other interventionObese cases with NAFLD
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of NAFLD and NASH at baseline, based on histological assessment
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 cohort
Including fibroscan and liver enzymes
Correlation between serum alanine aminotransferase and histological severity
Biomarkers predicting NAFLD and NASH in this cohort
* 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
Sponsors and contacts
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