Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Hospital Authority, Hong Kong.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00577044
First received: July 6, 2007
Last updated: December 15, 2008
Last verified: June 2008
  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

Study Type: Observational
Official Title: Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong: Natural History and Development of Liver Complications

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Hospital Authority, Hong Kong:
NAFLD

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014