Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT03849235
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pathophysiological Study of the Postprandial Human Liver (PLS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005934', 'term': 'Glucagon'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood tests and liver tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-18', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial phosphoproteomic changes in liver tissue in healthy individuals', 'timeFrame': '60 minutes after the meal administered at the study day', 'description': "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"}], 'secondaryOutcomes': [{'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', 'description': "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"}, {'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', 'description': "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"}, {'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', 'description': "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"}, {'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', 'description': "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 samples obtained after glucagon injection"}, {'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', 'description': "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 samples obtained after glucagon injection"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Fatty Liver']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://researchleaderprogramme.com/recipients/nicolai-wewer-albrechtsen/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will include partcipants with suspected NAFLD or cirrhosis based on clinical assessments referred for a liver biopsy and healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy participants (WP 1 , WP 4 , WP 5 )\n\nInclusion criteria: Healthy adults, 20 - 40 years old, non-smoker, BMI 20-25 kg/m2 , no chronical illnesses, no medication.\n\nExclusion criteria: Blood donation within the past 3 months, acute illness within 2 weeks\n\nNAFLD ( WP 2)\n\nInclusion criteria: Patients with clinical diagnosis of NAFL and indication for liver biopsy Exclusion criteria: Malignant disease, acute illness within the past 2 weeks.\n\nCirrhosis (WP 3)\n\nInclusion criteria: Patients with clinical diagnosis of cirrhosis and indication for liver biopsy.\n\nExclusion criteria:Malignant disease, acute illness within the past 2 weeks.'}, 'identificationModule': {'nctId': 'NCT03849235', 'acronym': 'PLS', 'briefTitle': 'A Pathophysiological Study of the Postprandial Human Liver (PLS)', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'A Pathophysiological Study of the Postprandial Human Liver (PLS)', 'orgStudyIdInfo': {'id': 'H-18052725'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Standardised meal or glucagon', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein) or 1mg glucagon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'state': 'Capital Region Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lise L Gluud, MD', 'role': 'CONTACT', 'email': 'lise.lotte.gluud.01@regionh.dk', 'phone': '+4538621964'}], 'facility': 'Gastrounit, Copenhagen University Hospital Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Juliana JV Grandt, MD', 'role': 'CONTACT', 'email': 'Juliana.josephine.vivian.grandt@regionh.dk', 'phone': '+45 38623862'}], 'overallOfficials': [{'name': 'Nicolai Jacob Wewer Albrechtsen, MD, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NNF Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark'}, {'name': 'Lise Lotte Gluud, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastrounit, Copenhagen University Hospital Hvidovre, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant hepatologist', 'investigatorFullName': 'Lise Gluud', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}