Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong
Primary Purpose
Fatty Liver
Status
Unknown status
Phase
Locations
China
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Fatty Liver focused on measuring NAFLD
Eligibility Criteria
Inclusion Criteria:
- 18-80 years old
- Gender: male and female
Exclusion Criteria:
- HBV patients and fatty liver HCV HIV
Sites / Locations
- Department of Medicine, Queen Mary Hospital
- Department of Pathology, Princess Margaret Hospital
- Department of Pathology, Queen Elizabeth Hospital
- Department of Pathology, Queen Mary Hospital
- Department of Pathology, Tuen Mun Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00577044
First Posted
July 6, 2007
Last Updated
December 15, 2008
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00577044
Brief Title
Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong
Official Title
Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong: Natural History and Development of Liver Complications
Study Type
Observational
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
The true incidence and prevalence of NAFLD in Hong Kong has not been determined. The natural history of NAFLD is not well defined partly because of differences in the exclusion limit of alcohol and the required histological criteria between studies. NAFLD is previously believed to be a benign non-progressive condition, but it has since been determined that a subset of patients can progress to cirrhosis and even hepatocellular carcinoma.
In fact in a recent histological review of NAFLD, fibrosis or liver cirrhosis was present in 15-50% of patients at index liver biopsy. The presence of obesity or type 2 diabetes mellitus are the strongest predictors of fibrosis. These same risk factors are also more common in patients with cryptogenic cirrhosis. Further evidence of the link between diabetes, obesity and NAFLD are mainly from the field of liver transplantation. In patients who underwent liver transplantation for cryptogenic liver cirrhosis, NAFLD recuured in a quarter of the hepatic allografts. The patients with recurrent NAFLD were more likely to be diabetic and had a higher body mass index (BMI) at the time of recurrent NAFLD. This suggests that NAFLD may have a significant role in the pathogenesis of crytogenic cirrhosis.
Although NAFLD was initially described as a slowly progressive disease, there are emerging data which shows that it can progress rapidly. Liver failure has even been described in patients with NAFLD after bariatric surgery, and a recent report described 5 cases of subacute liver failure in obese middle aged females with NAFLD related cirrhosis. NAFLD can also affect the progression of other diseases as well. Hepatic steatosis related to visceral obesity is a major independent risk factor for fibrogenesis related to chronic HCV hepatitis.
However, the prevalence of NAFLD and its interaction with chronic HBV, if any, is uncertain. This study aims to determine the prevalence of NAFLD in patients with unknown cause of hepatitis and to determine the histological fibrosis and inflammation in chronic HBV patients with NAFLD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
NAFLD
7. Study Design
Enrollment
600 (Anticipated)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
18-80 years old
Gender: male and female
Exclusion Criteria:
HBV patients and fatty liver HCV HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George K Lau, Dr
Organizational Affiliation
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Department of Pathology, Princess Margaret Hospital
City
Hong Kong
Country
China
Facility Name
Department of Pathology, Queen Elizabeth Hospital
City
Hong Kong
Country
China
Facility Name
Department of Pathology, Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Department of Pathology, Tuen Mun Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong
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