Nonalcoholic Fatty Liver Disease (NAFLD)
Conditions
Brief summary
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.
Interventions
OTHERCase Group
Obese cases with NAFLD
Sponsors
Chinese University of Hong Kong
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of NAFLD and NASH at baseline, based on histological assessment | Baseline | 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 | 1 year | Including fibroscan and liver enzymes |
| Correlation between serum alanine aminotransferase and histological severity | 1 year | — |
| Biomarkers predicting NAFLD and NASH in this cohort | 1 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 |
Countries
Hong Kong
Contacts
CONTACTAlice Pik Shan Kong, MD
Outcome results
None listed