Clinical Course and Biomarkers Associated With Nonalcoholic Fatty Liver Disease (NAFLD) in Chinese Patients With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Case Group.
- Who it may be relevant to
- Registry conditions: Nonalcoholic Fatty Liver Disease (NAFLD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Case Group
Obese cases with NAFLD
Primary outcome measures
- Prevalence of NAFLD and NASH at baseline, based on histological assessment [Time frame: Baseline]
- The clinical course predicting NAFLD and NASH in this cohort [Time frame: 1 year]
- Correlation between serum alanine aminotransferase and histological severity [Time frame: 1 year]
- Biomarkers predicting NAFLD and NASH in this cohort [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Hong Kong · 1 center
- Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward — Hong Kong
Identifiers
NCT: NCT07662356 · 2018.386