NCT00577044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
Last Updated

December 17, 2008

Status Verified

June 1, 2008

First QC Date

July 6, 2007

Last Update Submit

December 15, 2008

Conditions

Keywords

NAFLD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Gender: male and female

You may not qualify if:

  • HBV patients and fatty liver HCV HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Medicine, Queen Mary Hospital

Hong Kong, China

Location

Department of Pathology, Princess Margaret Hospital

Hong Kong, China

Location

Department of Pathology, Queen Elizabeth Hospital

Hong Kong, China

Location

Department of Pathology, Queen Mary Hospital

Hong Kong, China

Location

Department of Pathology, Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • George K Lau, Dr

    Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 6, 2007

First Posted

December 19, 2007

Study Start

June 1, 2004

Study Completion

December 1, 2007

Last Updated

December 17, 2008

Record last verified: 2008-06

Locations