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Completed

NCT Number: NCT03849235

A Pathophysiological Study of the Postprandial Human Liver (PLS)

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).

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Key information

Conditions

Cirrhosis Digestive System Diseases Fatty Liver Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region Denmark, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy participants (WP1 , WP4 , WP5 ):

Inclusion criteria

Healthy adults, 20 - 40 years old, non-smoker, BMI 20-25 kg/m2 , no chro-nical illnesses, no medication. Exclusion criteria: Blood donation within the past 3 months, acute illness within 2 weeks.

NAFLD (WP2, WP6):

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.

T2DM and NAFLD (WP7):

Inclusion criteria

Patients with clinical diagnosis of T2DM and NAFL and indication for liver biopsy. Exclusion criteria: Malignant disease, acute illness within the past 2 weeks and use of insulin.

Treatment and study plan

Standardised meal

Dietary Supplement

Standardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein).

Glucagon bolus

Drug

Intravenous bolus of 0.2 mg glucagon

Primary outcomes

  1. Postprandial phosphoproteomic changes in liver tissue in healthy individuals

    Time frame: 60 minutes after the meal administered at the study day

    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.

Secondary outcomes

  1. Postprandial phosphoproteomic changes in liver tissue between healthy participants and patients with cirrhosis or patients with NAFLD.

    Time frame: 60 minutes after the meal administered at the study day

    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 patients with cirrhosis and in patients with NAFLD and between healthy participants and patients with cirrhosis and patients with NAFLD.

  2. Postprandial proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals and compared to patients with cirrhosis and patients with NAFLD

    Time frame: 60 minutes after the meal administered at the study day

    Proteomic, metabolomic and transcriptomic changes will be performed using MS-based approaches and Next generation sequencing that allows identification of proteins, metabolites, RNA-transcripts in the liver. The comparison will be done between 'fasted' and 'postprandial' samples in healthy participants, patients with cirrhosis, and patients with NAFLD and between healthy participants and patients with cirrhosis and patients with NAFLD.

  3. 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

    Time frame: 120 minutes after the meal administered at the study day

    Proteomic, metabolomic and hormonal changes will be performed using MS-based approaches and ELISAs that allows identification and measurements of proteins, metabolites and hormones from the liver. The comparison will be done between 'fasted' and 'postprandial' samples in healthy individuals, patients with cirrhosis, and patients with NAFLD and between healthy participants and patients with cirrhosis and patients with NAFLD.

  4. Postprandial phosphoproteomics, proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals.

    Time frame: 30 minutes after the meal administered at the study day

    Phosphoproteomic, proteomic, metabolomic and transcriptomic changes will be performed using MS-based approaches and Next generation sequencing that allows identification of proteins, metabolites, RNA-transcripts in the liver. The comparison will be done between 'fasted' (before) and 'postprandial' (after) samples in healthy participants (paired).

  5. Postprandial proteomic, metabolomic and Peptidomic changes in blood obtained from liver vein and peripheral vein in healthy individuals.

    Time frame: 120 minutes after the meal administered at the study day

    Proteomic, metabolomic and hormonal changes will be performed using MS-based approaches and ELISAs that allows identification and measurements of proteins, metabolites and hormones from the liver. The comparison will be done between 'fasted' (before) and 'postprandial' (after) samples in in healthy participants (paired).

  6. Effect of exogenous glucagon on changes in liver phosphoproteomics, proteomics, metabolomics, and transcriptomics in healthy individuals and compared to patients with NAFLD and patients with T2DM and NAFLD.

    Time frame: 30 minutes after the glucagon administered at the study day

    Phosphoproteomic, proteomic, metabolomic and transcriptomic changes will be performed using MS-based approaches and Next generation sequencing that allows identification of proteins, metabolites, RNA-transcripts in the liver. The comparison will be done between 'fasted'/baseline samples and samples obtained after glucagon injection (paired) in healthy individuals, in patients with NAFLD, and in patients with T2DM and NAFLD and between healthy participants and patients with NAFLD and patients with T2DM and NAFLD.

  7. Effect of exogenous glucagon on changes in phosphoproteomics, proteomics, metabolomics and peptidomic in blood obtained from liver vein and peripheral vein in healthy individuals and compared to patients with NAFLD and patients with T2DM and NAFLD

    Time frame: 120 minutes after the glucagon administered at the study day

    Proteomic, metabolomic and hormonal changes will be performed using MS-based approaches and ELISAs that allows identification and measurements of proteins, metabolites and hormones from the liver. The comparison will be done between 'fasted'/baseline samples and samples obtained after glucagon injection (paired) in healthy individuals, in patients with NAFLD, and in patients with T2DM and NAFLD and between healthy participants and patients with NAFLD and patients with T2DM and NAFLD.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • University of Copenhagen

Registry information

Acronym: PLS

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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