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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
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Fatty Liver focused on measuring NAFLD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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

First Posted
July 6, 2007
Last Updated
December 15, 2008
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
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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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