Status:
COMPLETED
Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer. At present, there is no approved drug for NAFLD....
Eligibility Criteria
Inclusion
- Age 18 to 70 years
- Fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above
- Serum alanine aminotransferase (ALT) above 30 U/L in men and 19 U/L in women
- Informed written consent obtained
Exclusion
- Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160
- Alcohol consumption above 30 g per week in men or 20 g per week in women
- Alanine aminotransferase (ALT) above 10 times the upper limit of normal
- Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices
- Evidence of hepatocellular carcinoma
- Terminal illness or cancer, unless in complete remission for more than 5 years
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00868933
Start Date
February 1 2009
End Date
May 1 2012
Last Update
February 24 2014
Active Locations (1)
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1
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China