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Postprandial Lipotoxicity and Nonalcoholic Fatty Liver Disease

NCT03836443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-13

No results posted yet for this study

Summary

Nonalcoholic fatty liver disease (NAFLD) is mainly considered a nutrition-related disease and life-style/diet interventions showed some promising results. But in spite of this, there are no available markers to efficiently guide interventions. the hypothesize put farth by the investigators is that NAFLD patients develop postprandial abnormalities of plasma lipids upon "western diet" challenge, more severe in steatohepatitis (NASH) than in pure steatosis (NAFL), promoting liver injury. Our study aims to evaluate the presence of toxic lipids (such as free-fatty acids, ceramides, diacylglycerols, sphingolipids) in postprandial state after ingestion of a "western diet" in NAFLD patients. Consecutive patients (group 1: NAFL patients; group 2: NASH patients) with biopsy-proven NAFLD (liver biopsy \< 6 months) will be recruited during a period of 12 month. Blood samples will be drawn at fasting, 2hours, 4hours, 6hours and 8hours after ingestion of a "western diet" meal. Plasma lipid profiles using lipidomics, circulating markers of liver injury and inflammation will be analyzed. the investigators will also assess the hepatotoxicity of plasma from NAFL or NASH patients in-vitro.

Conditions

  • Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

OTHER

western diet" meal

A "western diet" meal (high saturated fat, high refined sugar, high fructose) will be administered in each group (800 kcal/meal) after an overnight fast.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Cosmin VOICAN · AP-HP, Beclere Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836443 on ClinicalTrials.gov