Clinical trial NCT03849235: A Pathophysiological Study of the Postprandial Human Liver (PLS)
Official title: A Pathophysiological Study of the Postprandial Human Liver (PLS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Fatty Liver
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2019-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include partcipants with suspected NAFLD or cirrhosis based on clinical assessments referred for a liver biopsy and healthy controls.

Brief summary: 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)


Eligibility 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.

Primary outcomes:
measure: Postprandial phosphoproteomic changes in liver tissue in healthy individuals
timeFrame: 60 minutes after the meal administered at the study day
Secondary outcomes:
measure: Postprandial phosphoproteomic changes in liver tissue between healthy participants and patients with cirrhosis or patients with NAFLD.
timeFrame: 60 minutes after the meal administered at the study day
measure: Postprandial proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals and compared to patients with cirrhosis and patients with NAFLD
timeFrame: 60 minutes after the meal administered at the study day
measure: Postprandial proteomic, metabolomic and Peptidomic changes in blood obtained from liver vein and peripheral vein in healthy individuals and compared to patients with cirrhosis and patients with NAFLD
timeFrame: 120 minutes after the meal administered at the study day
measure: Effect of exogenous glucagon on changes in liver phosphoproteomics, proteomics, metabolomics, and transcriptomics in healthy individuals.
timeFrame: 30 minutes after the meal administered at the study day
measure: Effect of exogenous glucagon on changes in phosphoproteomics, proteomics, metabolomics and peptidomic in blood obtained from liver vein and peripheral vein in healthy individuals
timeFrame: 120 minutes after the meal administered at the study day
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Gastrounit, Copenhagen University Hospital Hvidovre
state: Capital Region Denmark
Study officials:
affiliation: NNF Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
name: Nicolai Jacob Wewer Albrechtsen, MD, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastrounit, Copenhagen University Hospital Hvidovre, Denmark
name: Lise Lotte Gluud, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: