Clinical trial NCT06166368: the Bispebjerg Study of Diurnal Variations
Official title: the Bispebjerg Study of Diurnal Variations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diurnal
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2023-12-12
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the influence of time of day on the circulating concentrations of various biochemical markers in healthy men


Eligibility criteria: Inclusion Criteria:

* Medically healthy
* Normal sleep-wake pattern

Exclusion Criteria:

* acute or chronic medical diseases
* had worked nightshifts the last 14 days before the study
* transatlantic traveling the last 14 days before the study
* had been smoking the last 14 days before the study
* had an irregular sleep-wake pattern,
* didn't sleep 7-8 hours pr night
* were extreme morning- or evening types,
* had plasma hemoglobin \< 8.0 mmol/L
* ody mass index (BMI) \<18.5 kg/m2 or \>24.9 kg/m2.

Primary outcomes:
measure: hematology parameters
timeFrame: 24 hours
Secondary outcomes:
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
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital
name: Henriette P Sennels, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.