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NCT Number: NCT07662356

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

Alice Pik Shan Kong, MD

CONTACT

[email protected]

+852 3505 2648

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case Group

Other

Obese cases with NAFLD

Primary outcomes

  1. Prevalence of NAFLD and NASH at baseline, based on histological assessment

    Time frame: 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.

  2. The clinical course predicting NAFLD and NASH in this cohort

    Time frame: 1 year

    Including fibroscan and liver enzymes

  3. Correlation between serum alanine aminotransferase and histological severity

    Time frame: 1 year

  4. Biomarkers predicting NAFLD and NASH in this cohort

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Pik Shan Kong, MD

CONTACT

[email protected]

+852 3505 2648

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2030
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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