Effect of dietary lipid modification on nonalcoholic fatty liver disease in carriers of the PNPLA3 I148M genetic variant: an open label trial

Not Applicable

• Conditions: K76.0; Fatty (change of) liver, not elsewhere classified

• Registration Number: DRKS00007781
• Lead Sponsor: Saarland University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-25
• Study Completion: 2016-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with non-alcoholic fatty liver disease
2. Patients with the PNPLA3-Genotype (p.148MM and p.I148II)

Exclusion Criteria

•Known infection with viral hepatitis, HIV or cholestatic liver diseases (e.g. PBC, PSC).
•Presence of Diabetes Mellitus Type 2 (HbA1c = 7.5% (= 58 mmol/mol)
•Presence of Alcoholic Fatty Liver Disease
with a weekly alcohol consumption of > 21 drinks (> 30 g alcohol/Day) in men and >14 drinks (> 20 g alcohol/Day) in women (2)
•Presence of liver cirrhosis based on liver stiffness measurement (transient elastography = 13kPa FibroScan®,Echosens, Paris, France)
•Medications known to increase fatty liver (e.g. Amiodarone, Methotrexat) or to affect carbohydrate or lipid metabolism?
•Pregnancy
•Pacemaker
•Vegetarians or vegans

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in hepatic steatosis, as assessed using controlled attentuation parameter (CAP) after 4 weeks of oral omega-3 supplementation

Secondary Outcome Measures

Name	Time	Method
Changes to the following paramters after 4 weeks of oral omega 3 supplementation:<br><br>•Blood lipid profile (Total cholesterol, LDL-C, HDL-C, triglycerides)<br>•Liver function tests (e.g. AST, ALT, GGT, AP, Bilirubin, Albumin)<br>•Inflammatory markers<br>•Fasting plasma glucose, insulin and HbA1c <br>•Liver stiffness measurement (LSM) <br>