Status:
COMPLETED
Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver Disease
Lead Sponsor:
Harokopio University
Collaborating Sponsors:
University of Athens
Conditions:
Non-alcoholic Fatty Liver Disease (NAFLD)
Non-alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and non alcoholic ...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is a pathologic condition which involves both hepatic steatosis and non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (live...
Eligibility Criteria
Inclusion
- The inclusion criteria will be:
- Participants aged 18-65 years old,
- Participants with non-alcoholic fatty liver disease (NAFLD). NAFLD's diagnosis will be based on increased serum levels of alanine aminotransferase (ALT) above 1.5 times, with or without increased gamma-glutamyl transpeptidase (GGT) serum levels,
- BMI \>25 Kg/m2 (range 25-40 Kg/m2),
- The presence of hepatic steatosis and absence of other causes of hepatic steatosis and hepatic failure.
Exclusion
- The exclusion criteria will be:
- Detection of hepatitis B surface antigen (HBsAg) or antibodies against hepatitis C(anti-HCV) or antibodies against HIV,
- Alcohol intake \>210 or \>140 gr per week for men or women, respectively,
- Reception of potentially hepatotoxic drugs,
- Presence of systemic disease with potential liver involvement,
- Diabetes mellitus.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01894438
Start Date
April 1 2013
End Date
May 1 2017
Last Update
August 3 2017
Active Locations (1)
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1
Harokopio University
Kallithea, Attica, Greece, 17671