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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Case Group

    Other intervention

    Obese cases with NAFLD

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Control1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

The clinical course predicting NAFLD and NASH in this cohort

Including fibroscan and liver enzymes

Time frame
1 year
3

Correlation between serum alanine aminotransferase and histological severity

Time frame
1 year
4

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

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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