Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT06872060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005934', 'term': 'Glucagon'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood perfusion of the kidney', 'timeFrame': '7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).', 'description': 'we would like to measure blood perfusion of the kidneys over time'}], 'secondaryOutcomes': [{'measure': 'Blood flow of the renal arteries', 'timeFrame': '7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).'}, {'measure': 'blood oxygen saturation of the kidneys', 'timeFrame': '7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Diseases']}, 'descriptionModule': {'briefSummary': "This study will investigating the effects of glucagon on renal blood flow in humans using MRI technology. Glucagon, a hormone produced by the pancreas, plays a key role in regulating blood sugar levels. It has been shown to affect renal function, including electrolyte balance and blood flow, especially in conditions like type 2 diabetes where abnormal glucagon levels are common. The study aims to understand how glucagon affects regional blood flow in the kidneys, specifically the cortex and medulla, and whether these effects are mediated by glucagon receptors.\n\nThe study will be conducted on 10 healthy male participants aged 20-60 years. It involves three test days where participants will receive either glucagon, glucagon with a GLP-1 receptor antagonist, or placebo. Blood flow, glomerular filtration rate, and other renal functions will be measured using MRI. The study seeks to clarify whether glucagon's effects on the kidneys are linked to changes in regional blood flow and to determine if these effects are mediated solely by glucagon receptors."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal health confirmed through; Interview and Medical examination\n* Normal values with respect to blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function tests, and electrolytes\n* Informed consent\n\nExclusion Criteria:\n\n* Immunosuppressive treatment in the previous 12 months\n* Alcohol abuse\n* Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists, which, in the opinion of the principal investigator, may interfere with glucose metabolism\n* Use of lithium\n* Medical treatment that affects insulin secretion or the renin-angiotensin-aldosterone system\n* Liver disease (ALT \\> 2x normal value)\n* Renal impairment (serum creatinine \\> 130 µM and/or albuminuria)\n* Individuals with severe claustrophobia\n* Individuals with MR-incompatible foreign bodies\n* Individuals with hypertension'}, 'identificationModule': {'nctId': 'NCT06872060', 'briefTitle': 'The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.', 'orgStudyIdInfo': {'id': 'H-24012271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucagon', 'interventionNames': ['Drug: Glucagon', 'Drug: Glucagon+Exendin9-39', 'Drug: Sodium chloride']}, {'type': 'EXPERIMENTAL', 'label': 'Glucagon+Exendin9-39', 'interventionNames': ['Drug: Glucagon', 'Drug: Glucagon+Exendin9-39', 'Drug: Sodium chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride (Placebo comparator)', 'interventionNames': ['Drug: Glucagon', 'Drug: Glucagon+Exendin9-39', 'Drug: Sodium chloride']}], 'interventions': [{'name': 'Glucagon', 'type': 'DRUG', 'description': 'Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes.', 'armGroupLabels': ['Glucagon', 'Glucagon+Exendin9-39', 'Sodium chloride (Placebo comparator)']}, {'name': 'Glucagon+Exendin9-39', 'type': 'DRUG', 'description': 'Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes', 'armGroupLabels': ['Glucagon', 'Glucagon+Exendin9-39', 'Sodium chloride (Placebo comparator)']}, {'name': 'Sodium chloride', 'type': 'DRUG', 'description': 'Placebo (0.9% NaCl).', 'armGroupLabels': ['Glucagon', 'Glucagon+Exendin9-39', 'Sodium chloride (Placebo comparator)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, Associate Professor, PhD, MD', 'investigatorFullName': 'Ali Asmar', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}