Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-04-17 @ 10:11 AM
Study NCT ID:
NCT02357550
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007659', 'term': 'Ketones'}], 'ancestors': [{'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-15', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose metabolism in brain, CMR', 'timeFrame': 't=240-360 minutes', 'description': 'cerebral glucose metabolism measured by PET tracer during the above time frame'}], 'secondaryOutcomes': [{'measure': 'Stress metabolism', 'timeFrame': '0-360 minutes', 'description': 'growth hormone, cortisol, glucagon, adrenalin, ghrelin.'}, {'measure': 'Oxygen use', 'timeFrame': 'T=150-200 minutes', 'description': 'cerebral oxygen consumption measured by PET tracer during the above time frame'}, {'measure': 'cerebral blood flow', 'timeFrame': 't=180-250 minutes', 'description': 'cerebral blood flow measured by PET tracer during the above time frame'}, {'measure': 'Intramuscular signaling', 'timeFrame': 't= 260 minutes', 'description': 'protein and insulin signaling in muscle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ketone Body Metabolism', 'Brain Metabolism']}, 'referencesModule': {'references': [{'pmid': '33074729', 'type': 'DERIVED', 'citation': 'Lauritzen ES, Svart MV, Voss T, Moller N, Bjerre M. Impact of Acutely Increased Endogenous- and Exogenous Ketone Bodies on FGF21 Levels in Humans. Endocr Res. 2021 Feb;46(1):20-27. doi: 10.1080/07435800.2020.1831015. Epub 2020 Oct 19.'}, {'pmid': '30327354', 'type': 'DERIVED', 'citation': 'Lauritsen KM, Sondergaard E, Svart M, Moller N, Gormsen LC. Ketone Body Infusion Increases Circulating Erythropoietin and Bone Marrow Glucose Uptake. Diabetes Care. 2018 Dec;41(12):e152-e154. doi: 10.2337/dc18-1421. Epub 2018 Oct 16. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.\n\nHypotheses\n\n1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.\n2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.\n3. Altered oxygen consumption during hyperketonemia in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* BMI 20-30 kg/m2\n\nExclusion Criteria:\n\n* smoking\n* alcohol abuse\n* severe comorbidity\n* blood donation 6 month prior\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT02357550', 'briefTitle': 'Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study', 'orgStudyIdInfo': {'id': 'RM-1-10-72-106-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Hyperketonaemia', 'description': 'Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy', 'interventionNames': ['Drug: ketone']}], 'interventions': [{'name': 'ketone', 'type': 'DRUG', 'description': '3-OHB is infused intravenously.', 'armGroupLabels': ['Hyperketonaemia']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Saline infusion.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Mads Svart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University / Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}