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

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.

Study Overview

• Status: Recruiting
• Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: Other: Case Group

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Alice Pik Shan Kong, MD; Phone Number: +852 3505 2648; Email: alicekong@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Hong Kong, New Territories, Hong Kong, 99977
      • Recruiting
      • 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
      • Contact: Alice Pik Shan Kong, MD; Phone Number: +852 3505 2648; Email: alicekong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing obesity surgery at The Prince of Wales Hospital。

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Obese cases without NAFLD	Other: Case Group; Obese cases with NAFLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
The clinical course predicting NAFLD and NASH in this cohort	Including fibroscan and liver enzymes	1 year
Correlation between serum alanine aminotransferase and histological severity		1 year
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	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Estimated): October 19, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Health Care Economics and Organizations; Financing, Organized; Economics; Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Diagnosis-Related Groups
• Other Study ID Numbers: 2018.386

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No