CirrhosisPLSNCT03849235
A Pathophysiological Study of the Postprandial Human Liver (PLS)
A study testing Standardised meal and Glucagon bolus in people with Cirrhosis and Fatty Liver, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Fatty Liver
- What is being tested?
- Standardised meal and Glucagon bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Mar 2019to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gastrounit, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region Denmark, 2650
About this study
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).
- Conditions
- Cirrhosis, Fatty Liver
- Being tested
- Standardised meal, Glucagon bolus
- Medical subject headings
- Fibrosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised mealDietary supplement
Standardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein).
Glucagon bolusDrug
Intravenous bolus of 0.2 mg glucagon
| Study group | Role | What they receive |
|---|---|---|
| Blood tests and liver biopsies after fasting or ingestion of a standardized meal | Experimental | Participants 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. Receives: Dietary Supplement: Standardised meal |
| Blood tests and liver biopsies before and after a standardized meal | Experimental | A 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. Receives: Dietary Supplement: Standardised meal |
| Blood tests and liver biopsies before and after a bolus of glucagon | Experimental | A 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. Receives: Drug: Glucagon bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 120 minutes after the meal administered at the study day
Postprandial phosphoproteomics, proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals.
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).
Measured: 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.
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).
Measured: 120 minutes after the meal administered at the study day
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.
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.
Measured: 30 minutes after the glucagon administered at the study day
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
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.
Measured: 120 minutes after the glucagon administered at the study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start2 Mar 2019
- Primary completion21 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Lise Gluud, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai Jacob Wewer Albrechtsen, MD, Assoc. Prof., Principal investigator, NNF Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, DenmarkLise Lotte Gluud, MD, Prof, Principal investigator, Gastrounit, Copenhagen University Hospital Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849235
- Sponsor's protocol ID
- H-18052725
- Acronym
- PLS
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2019
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pathophysiological Study of the Postprandial Human Liver (PLS)
- ClinicalTrials.gov ID
- NCT03849235
- Acronym / sponsor ID
- PLS / H-18052725
- Conditions
- Cirrhosis, Fatty Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood tests and liver biopsies after fasting or ingestion of a standardized meal | Experimental | Dietary Supplement: Standardised mealParticipants 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 | Experimental | Dietary Supplement: Standardised mealA 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 | Experimental | Drug: Glucagon bolusA 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised mealStandardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein). | Dietary supplement | Blood tests and liver biopsies after fasting or ingestion of a standardized meal, Blood tests and liver biopsies before and after a standardized meal |
| Glucagon bolusIntravenous bolus of 0.2 mg glucagon | Drug | Blood tests and liver biopsies before and after a bolus of glucagon |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai Jacob Wewer Albrechtsen, MD, Assoc. Prof. principal investigator
NNF Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
Lise Lotte Gluud, MD, Prof principal investigator
Gastrounit, Copenhagen University Hospital Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardised meal and Glucagon bolus in people with Cirrhosis and Fatty Liver, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial phosphoproteomic changes in liver tissue in healthy individuals (time frame: 60 minutes after the meal administered at the study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.