A Pathophysiological Study of the Postprandial Human Liver (PLS)
PLS
1 other identifier
interventional
87
1 country
1
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 seven 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), patients with NAFLD (WP6), and patients with T2DM and NAFLD (WP7).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
March 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJuly 6, 2026
July 1, 2026
6.5 years
February 20, 2019
July 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial phosphoproteomic changes in liver tissue in healthy individuals
Phosphorproteomic changes will be performed using MS-based approach that allows identification of phosphorylations sites at proteins in the liver. The comparison will be done between 'fasted' and 'postprandial' samples in healthy individuals.
60 minutes after the meal administered at the study day
Secondary Outcomes (7)
Postprandial phosphoproteomic changes in liver tissue between healthy participants and patients with cirrhosis or patients with NAFLD.
60 minutes after the meal administered at the study day
Postprandial proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals and compared to patients with cirrhosis and patients with NAFLD
60 minutes after the meal administered at the study day
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
120 minutes after the meal administered at the study day
Postprandial phosphoproteomics, proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals.
30 minutes after the meal administered at the study day
Postprandial proteomic, metabolomic and Peptidomic changes in blood obtained from liver vein and peripheral vein in healthy individuals.
120 minutes after the meal administered at the study day
- +2 more secondary outcomes
Study Arms (3)
Blood tests and liver biopsies after fasting or ingestion of a standardized meal
EXPERIMENTALParticipants randomized to the meal group consume, over a period of five minutes, a standardized liquid meal (Nutridrink Standard, 200 mL, 300 kcal, Nutricia). Participants randomized to the fasting group remain fasted for one hour after arrival. A transjugular liver biopsy is then performed at minute 60. Blood samples are obtained throughout the study day.
Blood tests and liver biopsies before and after a standardized meal
EXPERIMENTALA transjugular liver biopsy is performed, followed by ingestion of a standardized liquid meal (Nutridrink Standard, 200 mL, 300 kcal, Nutricia; 16% protein, 49% carbohydrate, 35% fat). A second transjugular liver biopsy is then performed 30 minutes after meal ingestion. Blood samples are obtained throughout the study day.
Blood tests and liver biopsies before and after a bolus of glucagon
EXPERIMENTALA transjugular liver biopsy is performed, followed by an intravenous bolus of 0.2 mg glucagon. A second transjugular liver biopsy is then performed 30 minutes after meal ingestion. Blood samples are obtained throughout the study day.
Interventions
Standardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein).
Intravenous bolus of 0.2 mg glucagon
Eligibility Criteria
You may not qualify if:
- NAFLD (WP2, WP6):
- Cirrhosis (WP 3):
- T2DM and NAFLD (WP7):
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital, Hvidovrelead
- University of Copenhagencollaborator
Study Sites (1)
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Denmark, 2650, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolai Jacob Wewer Albrechtsen, MD, Assoc. Prof.
NNF Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
- PRINCIPAL INVESTIGATOR
Lise Lotte Gluud, MD, Prof
Gastrounit, Copenhagen University Hospital Hvidovre, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant hepatologist
Study Record Dates
First Submitted
February 20, 2019
First Posted
February 21, 2019
Study Start
March 2, 2019
Primary Completion
August 21, 2025
Study Completion
September 1, 2025
Last Updated
July 6, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share