Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-28 @ 2:56 PM
Study NCT ID:
NCT04337268
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2020-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of GLP-1 on Renal Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T2* signal', 'timeFrame': '1 hour', 'description': 'Changes in T2\\* signal in renal cortex and medulla'}, {'measure': 'Arterial Spin Labeled (ASL)', 'timeFrame': '1 hour', 'description': 'Changes in Arterial Spin Labeled (ASL) MRI Perfusion Imaging in renal cortex and medulla'}, {'measure': 'Renal Artery Flow Phase (RAF)', 'timeFrame': '1 hour', 'description': 'Changes in Renal Artery Flow Phase (RAF)-Contrast Magnetic Resonance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucagon-like peptide-1', 'kidney', 'renal hemodynamics', 'renal blood flow'], 'conditions': ['The GLP-1-mediated Gut-kidney Axis']}, 'referencesModule': {'references': [{'pmid': '17928588', 'type': 'BACKGROUND', 'citation': 'Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.'}, {'pmid': '17475961', 'type': 'BACKGROUND', 'citation': 'Korner M, Stockli M, Waser B, Reubi JC. GLP-1 receptor expression in human tumors and human normal tissues: potential for in vivo targeting. J Nucl Med. 2007 May;48(5):736-43. doi: 10.2967/jnumed.106.038679.'}, {'pmid': '24467746', 'type': 'BACKGROUND', 'citation': 'Pyke C, Heller RS, Kirk RK, Orskov C, Reedtz-Runge S, Kaastrup P, Hvelplund A, Bardram L, Calatayud D, Knudsen LB. GLP-1 receptor localization in monkey and human tissue: novel distribution revealed with extensively validated monoclonal antibody. Endocrinology. 2014 Apr;155(4):1280-90. doi: 10.1210/en.2013-1934. Epub 2014 Jan 27.'}, {'pmid': '25670826', 'type': 'BACKGROUND', 'citation': 'Asmar A, Simonsen L, Asmar M, Madsbad S, Holst JJ, Frandsen E, Moro C, Jonassen T, Bulow J. Renal extraction and acute effects of glucagon-like peptide-1 on central and renal hemodynamics in healthy men. Am J Physiol Endocrinol Metab. 2015 Apr 15;308(8):E641-9. doi: 10.1152/ajpendo.00429.2014. Epub 2015 Feb 10.'}, {'pmid': '26956188', 'type': 'BACKGROUND', 'citation': 'Asmar A, Simonsen L, Asmar M, Madsbad S, Holst JJ, Frandsen E, Moro C, Sorensen CM, Jonassen T, Bulow J. Glucagon-like peptide-1 does not have acute effects on central or renal hemodynamics in patients with type 2 diabetes without nephropathy. Am J Physiol Endocrinol Metab. 2016 May 1;310(9):E744-53. doi: 10.1152/ajpendo.00518.2015. Epub 2016 Mar 8.'}, {'pmid': '28174344', 'type': 'BACKGROUND', 'citation': 'Asmar A, Asmar M, Simonsen L, Madsbad S, Holst JJ, Hartmann B, Sorensen CM, Bulow J. Glucagon-like peptide-1 elicits vasodilation in adipose tissue and skeletal muscle in healthy men. Physiol Rep. 2017 Feb;5(3):e13073. doi: 10.14814/phy2.13073.'}, {'pmid': '23463656', 'type': 'BACKGROUND', 'citation': 'Skov J, Dejgaard A, Frokiaer J, Holst JJ, Jonassen T, Rittig S, Christiansen JS. Glucagon-like peptide-1 (GLP-1): effect on kidney hemodynamics and renin-angiotensin-aldosterone system in healthy men. J Clin Endocrinol Metab. 2013 Apr;98(4):E664-71. doi: 10.1210/jc.2012-3855. Epub 2013 Mar 5.'}, {'pmid': '30835273', 'type': 'BACKGROUND', 'citation': 'Asmar A, Cramon PK, Simonsen L, Asmar M, Sorensen CM, Madsbad S, Moro C, Hartmann B, Jensen BL, Holst JJ, Bulow J. Extracellular Fluid Volume Expansion Uncovers a Natriuretic Action of GLP-1: A Functional GLP-1-Renal Axis in Man. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2509-2519. doi: 10.1210/jc.2019-00004.'}, {'pmid': '36734354', 'type': 'DERIVED', 'citation': 'Haddock B, Kristensen KB, Tayyab M, Larsson HBW, Lindberg U, Vestergaard M, Francis S, Jensen BL, Andersen UB, Asmar A. GLP-1 Promotes Cortical and Medullary Perfusion in the Human Kidney and Maintains Renal Oxygenation During NaCl Loading. J Am Heart Assoc. 2023 Feb 7;12(3):e027712. doi: 10.1161/JAHA.122.027712. Epub 2023 Feb 3.'}]}, 'descriptionModule': {'briefSummary': "This study investigates the hypothesis, that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation.", 'detailedDescription': "Human studies have recently demonstrated a significant natriuretic effect of GLP-1 when the extracellular fluid volume (ECFV) is expanded by intravenous sodium-loading; in these studies, there was a suppression of ANG II with no change in net renal hemodynamics, pointing to a tubular mechanism for reduced NaCl reabsorption secondary to the ANG II suppression. In the current randomized and controlled study, investigators aim to test the hypothesis that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation. Thus, contributing to the renoprotective action of GLP-1.\n\nUnder fixed sodium intake for 4 days before each study day, 10 healthy male participants will be investigated during a 1-hour infusion of GLP-1 (1.5 pmol/kg/min) or vehicle together with an intravenous infusion of 0.9% NaCl. Interleaved measurements of RAF, oxygenation (T2\\*) and perfusion by arterial spin labeling in the renal cortex and medulla at fixed time points will be conducted, using Magnetic Resonance Imaging (MRI)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal health demonstrated by medical examination.\n* Normal values for fasting plasma glucose, total cholesterol, triglyceride, HDL, LDL, creatinine, AST, ALT and electrolyte concentrations.\n\nExclusion Criteria:\n\n* Immunosuppressive treatment for the previous 12 months.\n* Alcohol abuse.\n* Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists that, in the opinion of the investigator, may interfere with glucose metabolism.\n* Use of lithium.\n* Medical treatment that affects insulin secretion or cardiovascular efficacy goals.\n* Liver disease (ALT\\> 2 x normal value).\n* Renal impairment (creatinine\\> 130 µM and / or albuminuria).\n* Severe claustrophobia.\n* MRI incompatible foreign bodies.'}, 'identificationModule': {'nctId': 'NCT04337268', 'acronym': 'GLP1RRBF', 'briefTitle': 'Acute Effects of GLP-1 on Renal Hemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Acute Effects of GLP-1 on Renal Hemodynamics: Simultaneous Perfusion and Oxygenation Measurements in Cortex and Medulla Using Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'H-18050603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'human glucagon-like peptide-1', 'description': 'Intervention:\n\nDrug: human glucagon-like peptide-1 Other names: GLP-1', 'interventionNames': ['Drug: Glucagon-Like Peptide 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intervention:\n\nDrug: Placebo (saline) Other names: Placebo for human glucagon-like peptide-1', 'interventionNames': ['Drug: saline 0.9%']}], 'interventions': [{'name': 'Glucagon-Like Peptide 1', 'type': 'DRUG', 'otherNames': ['GLP-1'], 'description': 'Intravenous infusion (1.5 pmol/kg/min) for 60 min.', 'armGroupLabels': ['human glucagon-like peptide-1']}, {'name': 'saline 0.9%', 'type': 'DRUG', 'otherNames': ['Placebo for GLP-1'], 'description': 'Intravenous infusion for 60 min.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet - Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Ali Asmar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Cardiovascular and Renal Research, University of Southern Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ali Asmar', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}