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Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Hospital Authority, Hong Kong
The University of Hong Kong
Information provided by: Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT00577044
  Purpose

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.


Condition
Fatty Liver

MedlinePlus related topics: Cirrhosis Diabetes Liver Diseases Obesity
U.S. FDA Resources
Study Type: Observational
Official Title: Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong: Natural History and Development of Liver Complications

Further study details as provided by Hospital Authority, Hong Kong:

Estimated Enrollment: 600
Study Start Date: June 2004
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 18-80 years old
  • Gender: male and female

Exclusion Criteria:

  • HBV patients and fatty liver HCV HIV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577044

Locations
China
Department of Medicine, Queen Mary Hospital
Hong Kong, China
Department of Pathology, Queen Mary Hospital
Hong Kong, China
Department of Pathology, Queen Elizabeth Hospital
Hong Kong, China
Department of Pathology, Princess Margaret Hospital
Hong Kong, China
Department of Pathology, Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: George K Lau, Dr Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
  More Information

Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Study ID Numbers: UW 05-120 T/783, HARECCTR0500006, KW/EX/05-036
Study First Received: July 6, 2007
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00577044  
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
NAFLD

Study placed in the following topic categories:
Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on January 16, 2009