Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-28 @ 12:14 PM
Study NCT ID:
NCT06208904
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-14
First Post:
2024-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619446', 'term': 'gastric inhibitory polypeptide (3-30)-amide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Plasma glucose', 'timeFrame': '0-180 minutes', 'description': 'Peak, nadir and iAUC'}, {'measure': 'Gastric emptying rate', 'timeFrame': '-45-0 minutes', 'description': 'Plasma acetaminophen, baseline'}, {'measure': 'Gastric emptying rate', 'timeFrame': '0-180 minutes', 'description': 'Plasma acetaminophen, peak and time to peak'}, {'measure': 'Plasma GIP(3-30)NH2', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Plasma GIP(3-30)NH2', 'timeFrame': '0-180 minutes', 'description': 'Peak and iAUC'}], 'primaryOutcomes': [{'measure': 'Nadir systolic blood pressure (SBP) (mmHg)', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Nadir systolic blood pressure (mmHg)', 'timeFrame': '0-180 minutes', 'description': 'Nadir and time to nadir'}], 'secondaryOutcomes': [{'measure': 'Occurrence of PPH', 'timeFrame': '0-180 minutes', 'description': '(Yes/No) PPH is defined as either a drop in SBP \\>20 mmHg from baseline or SBP \\<90 mmHg'}, {'measure': 'Systolic blood pressure (mmHg)', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Systolic blood pressure (mmHg)', 'timeFrame': '0-180 minutes', 'description': 'Peak, nadir and iAUC (incremental area under the curve)'}, {'measure': 'Diastolic blood pressure (mmHg)', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Diastolic blood pressure (mmHg)', 'timeFrame': '0-180 minutes', 'description': 'Peak, nadir and iAUC'}, {'measure': 'Heart rate (beats/min)', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Heart rate (beats/min)', 'timeFrame': '0-180 minutes', 'description': 'Peak, nadir and iAUC'}, {'measure': 'Stroke volumen (ml)', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Stroke volumen (ml)', 'timeFrame': '0-180 minutes', 'description': 'Peak, nadir and iAUC'}, {'measure': 'Cardiac output (l/min)', 'timeFrame': '-45-0 minutes', 'description': 'Baseline'}, {'measure': 'Cardiac output (l/min)', 'timeFrame': '0-180 minutes', 'description': 'Peak, nadir and iAUC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postprandial hypotension', 'Glucose-dependent insulinotropic polypeptide', 'GIP', 'GIP receptor antagonist', 'GIP(3-30)NH2'], 'conditions': ['PostPrandial Hypotension']}, 'descriptionModule': {'briefSummary': 'The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)', 'detailedDescription': 'The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-85 years\n2. History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion\n3. Informed consent\n\nExclusion Criteria:\n\n1. Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories\n2. Treatment with antihypertensives\n3. Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit\n4. Allergy or intolerance to ingredients included in the mixed meal\n5. Any ongoing medication that the investigator evaluates would interfere with trial participation\n6. Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses\n7. Anaemia (haemoglobin below normal range \\<7.3 mmol/L for women and \\<8.3 mmol/L for men)\n8. Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) \\<45 ml/min/1.73 m2) at screening\n9. Known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (ALT) \\> three times the upper limit of normal at screening\n10. Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial\n11. Alcohol/drug abuse as per discretion of the investigators\n12. Pregnancy or breastfeeding\n13. Participation in any other clinical trial during study period\n14. Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator"}, 'identificationModule': {'nctId': 'NCT06208904', 'acronym': 'GA-21', 'briefTitle': 'The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension', 'orgStudyIdInfo': {'id': 'GIPR-Ant-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist)', 'description': 'Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min', 'interventionNames': ['Other: Intravenous infusion of GIPRA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin', 'interventionNames': ['Other: Intravenous infusion of saline']}], 'interventions': [{'name': 'Intravenous infusion of GIPRA', 'type': 'OTHER', 'otherNames': ['GIP(3-30)NH2'], 'description': 'Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days', 'armGroupLabels': ['GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist)']}, {'name': 'Intravenous infusion of saline', 'type': 'OTHER', 'otherNames': ['Placebo (Saline)'], 'description': 'Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Clinical Metabolic Research', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lise Wilki-Kurtzhals', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Gentofte, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor and PhD student', 'investigatorFullName': 'lise wilki-kurtzhals', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}