Non-alcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
Effect of a Mediterranean Lifestyle Intervention on Biochemical and Clinical Characteristics of Patients With Non-alcoholic Fatty Liver Disease.
Verified date | August 2017 |
Source | Harokopio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 steatohepatitis (NASH), as the result of fat accumulation in the liver (liver
fat >5-10% of liver weight), not due to excess alcohol consumption or other causes of
steatosis.
At present, no medication or surgical procedure has been approved for treating NAFLD and
lifestyle modifications remain the cornerstone therapy targeting both at weight reduction for
overweight subjects and at prevention of overweight for the normal weight individuals. Given
that a Mediterranean dietary pattern has a beneficial effect both on the prevention and the
resolution of the metabolic syndrome, the main aim of the present study is to implement and
evaluate the potential benefits of an intervention based on the Mediterranean lifestyle in a
sample of patients with NAFLD.
Status | Completed |
Enrollment | 63 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Greece | Harokopio University | Kallithea | Attiki |
Lead Sponsor | Collaborator |
---|---|
Harokopio University | University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum levels of alanine aminotransferase (ALT) | Clinically useful reduction in ALT, defined as the restoration of ALT within normal limits or reduction of ALT in >50% of its initial value. | Within 6 months | |
Secondary | Gamma-glutamyl transpeptidase (GGT) | Restore of GGT levels within normal limits (i.e. GGT<30 IU/L). | Within 6 months | |
Secondary | Liver stiffness | Improved liver stiffness as estimated with elastography. | Within 6 months | |
Secondary | Inflammatory and oxidative stress markers | Improved inflammatory markers (TNF-a, IL-6, IL-8, adiponectin) and oxidative stress markers (ex vivo serum resistance to oxidation, measurement of the compounds that react with thiobarbituric acid-TBARS, activity of glutathione peroxidase) as well as lipid/glucose metabolism improvement (triglycerides, HDL, LDL, total cholesterol, insulin resistance index). | Within 6 months |
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