A Pathophysiological Study of the Postprandial Human Liver (PLS)

Copenhagen University Hospital, Hvidovre

Status: Enrolling

Conditions: Fatty Liver; Cirrhosis

Treatments: Dietary Supplement: Standardised meal or glucagon

Study type: Observational

Funder types: Other

Identifiers

NCT03849235

H-18052725

Details and patient eligibility

About

Fatty liver disease is a globally widespread disease The identification of valid biomarkers and targets for potential treatments requires in-depth knowledge about the pathophysiology of the postprandial liver. The study will consist of five work packages (WP) including blood tests and liver biopsies taken after fasting or ingestion of a standardized meal in: healthy controls (WP 1), patients with NAFLD (WP 2), and patients with cirrhosis (WP 3) ; before and after a standardised meal in healthy controls (WP 4), and before and after glucagon in healthy controls (WP5)

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy participants (WP 1 , WP 4 , WP 5 )

Inclusion criteria: Healthy adults, 20 - 40 years old, non-smoker, BMI 20-25 kg/m2 , no chronical illnesses, no medication.

Exclusion criteria: Blood donation within the past 3 months, acute illness within 2 weeks

NAFLD ( WP 2)

Inclusion criteria: Patients with clinical diagnosis of NAFL and indication for liver biopsy Exclusion criteria: Malignant disease, acute illness within the past 2 weeks.

Cirrhosis (WP 3)

Inclusion criteria: Patients with clinical diagnosis of cirrhosis and indication for liver biopsy.

Exclusion criteria:Malignant disease, acute illness within the past 2 weeks.