Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-02 @ 1:24 AM
Study NCT ID:
NCT06166368
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Bispebjerg Study of Diurnal Variations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002940', 'term': 'Circadian Rhythm'}], 'ancestors': [{'id': 'D010507', 'term': 'Periodicity'}, {'id': 'D002909', 'term': 'Chronobiology Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hematology parameters', 'timeFrame': '24 hours', 'description': 'Composite measurement of hematological measurements'}], 'secondaryOutcomes': [{'measure': 'Plasma Levels of Glucagon', 'timeFrame': '24 hours'}, {'measure': 'Plasma levels of GLP-1', 'timeFrame': '24 hours'}, {'measure': 'Plasma levels of GIP', 'timeFrame': '24 hours'}, {'measure': 'Plasma levels of c-peptide', 'timeFrame': '24 hours'}, {'measure': 'Plasma levels of glucose', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diurnal']}, 'referencesModule': {'references': [{'pmid': '21988588', 'type': 'BACKGROUND', 'citation': 'Sennels HP, Jorgensen HL, Hansen AL, Goetze JP, Fahrenkrug J. Diurnal variation of hematology parameters in healthy young males: the Bispebjerg study of diurnal variations. Scand J Clin Lab Invest. 2011 Nov;71(7):532-41. doi: 10.3109/00365513.2011.602422.'}, {'pmid': '22282468', 'type': 'BACKGROUND', 'citation': 'Goetze JP, Jorgensen HL, Sennels HP, Fahrenkrug J. Diurnal plasma concentrations of natriuretic propeptides in healthy young males. Clin Chem. 2012 Apr;58(4):789-92. doi: 10.1373/clinchem.2011.178921. Epub 2012 Jan 26. No abstract available.'}, {'pmid': '22397709', 'type': 'BACKGROUND', 'citation': 'Sennels HP, Jorgensen HL, Goetze JP, Fahrenkrug J. Rhythmic 24-hour variations of frequently used clinical biochemical parameters in healthy young males--the Bispebjerg study of diurnal variations. Scand J Clin Lab Invest. 2012 Jul;72(4):287-95. doi: 10.3109/00365513.2012.662281. Epub 2012 Mar 8.'}, {'pmid': '24571735', 'type': 'BACKGROUND', 'citation': 'Timm A, Fahrenkrug J, Jorgensen HL, Sennels HP, Goetze JP. Diurnal variation of von Willebrand factor in plasma: the Bispebjerg study of diurnal variations. Eur J Haematol. 2014 Jul;93(1):48-53. doi: 10.1111/ejh.12298. Epub 2014 Mar 18.'}, {'pmid': '26378655', 'type': 'BACKGROUND', 'citation': 'Sennels HP, Jorgensen HL, Fahrenkrug J. Diurnal changes of biochemical metabolic markers in healthy young males - the Bispebjerg study of diurnal variations. Scand J Clin Lab Invest. 2015;75(8):686-92. doi: 10.3109/00365513.2015.1080385. Epub 2015 Sep 17.'}, {'pmid': '27494182', 'type': 'BACKGROUND', 'citation': 'Heegaard NH, Carlsen AL, Lilje B, Ng KL, Ronne ME, Jorgensen HL, Sennels H, Fahrenkrug J. Diurnal Variations of Human Circulating Cell-Free Micro-RNA. PLoS One. 2016 Aug 5;11(8):e0160577. doi: 10.1371/journal.pone.0160577. eCollection 2016.'}, {'pmid': '31247945', 'type': 'BACKGROUND', 'citation': 'Schroor MM, Sennels HP, Fahrenkrug J, Jorgensen HL, Plat J, Mensink RP. Diurnal Variation of Markers for Cholesterol Synthesis, Cholesterol Absorption, and Bile Acid Synthesis: A Systematic Review and the Bispebjerg Study of Diurnal Variations. Nutrients. 2019 Jun 26;11(7):1439. doi: 10.3390/nu11071439.'}, {'pmid': '32820681', 'type': 'BACKGROUND', 'citation': 'Rehfeld JF, Sennels HP, Jorgensen HL, Fahrenkrug J. Circadian variations in plasma concentrations of cholecystokinin and gastrin in man. Scand J Clin Lab Invest. 2020 Nov;80(7):546-551. doi: 10.1080/00365513.2020.1804072. Epub 2020 Aug 21.'}, {'pmid': '38481208', 'type': 'DERIVED', 'citation': 'Zilstorff DB, Richter MM, Hannibal J, Jorgensen HL, Sennels HP, Wewer Albrechtsen NJ. Secretion of glucagon, GLP-1 and GIP may be affected by circadian rhythm in healthy males. BMC Endocr Disord. 2024 Mar 14;24(1):38. doi: 10.1186/s12902-024-01566-9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the influence of time of day on the circulating concentrations of various biochemical markers in healthy men'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medically healthy\n* Normal sleep-wake pattern\n\nExclusion Criteria:\n\n* acute or chronic medical diseases\n* had worked nightshifts the last 14 days before the study\n* transatlantic traveling the last 14 days before the study\n* had been smoking the last 14 days before the study\n* had an irregular sleep-wake pattern,\n* didn't sleep 7-8 hours pr night\n* were extreme morning- or evening types,\n* had plasma hemoglobin \\< 8.0 mmol/L\n* ody mass index (BMI) \\<18.5 kg/m2 or \\>24.9 kg/m2."}, 'identificationModule': {'nctId': 'NCT06166368', 'acronym': 'DIURNAL', 'briefTitle': 'the Bispebjerg Study of Diurnal Variations', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'the Bispebjerg Study of Diurnal Variations', 'orgStudyIdInfo': {'id': 'Diurnal variations'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'diurnal variations', 'description': 'Venous blood samples were obtained under standardized conditions from 24 healthy young men every third hour through 24 hours', 'interventionNames': ['Other: Diurnal variation']}], 'interventions': [{'name': 'Diurnal variation', 'type': 'OTHER', 'description': 'Venous blood samples were obtained under standardized circumstances from 24 healthy young men every third hour through 24 hours, nine time points in total.', 'armGroupLabels': ['diurnal variations']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Henriette P Sennels, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not allowed by ethical committe'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD.', 'investigatorFullName': 'Henriette P. Sennels', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}