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

NCT07662356 | Recruiting

• 1 other identifier: 2018.386
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Control

Obese cases without NAFLD

Other: Case Group

Interventions

Case Group OTHER

Obese cases with NAFLD

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing obesity surgery at The Prince of Wales Hospital。

You may qualify if:

• Age 18 years or above
• Chinese ethnicity
• Patient undergoing obesity surgery at The Prince of Wales Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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, 99977, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Baseline liver biopsies will be taken laparoscopically during surgery. Four pieces of liver tissue will be obtained. The first piece will be sent to the Department of Anatomical and Cellular Pathology for assessment and scoring. 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 second piece of liver tissue will be fixed in formalin for additional antibody staining. The third piece will be used for single cell RNA sequencing and the fourth piece will be frozen immediately for biochemical study. Clotted blood and EDTA blood will be taken for future biochemical and genetic studies.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diagnosis-Related Groups

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations

Central Study Contacts

Alice Pik Shan Kong, MD

CONTACT

+852 3505 2648; alicekong@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: June 23, 2026
• Study Start: December 16, 2019
• Primary Completion (Estimated): October 19, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 23, 2026

Record last verified: 2026-03

Locations

HK (1)