DiurnalDIURNALNCT06166368

the Bispebjerg Study of Diurnal Variations

A study testing Diurnal variation in people with Diurnal, run by Bispebjerg Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the influence of time of day on the circulating concentrations of various biochemical markers in healthy men Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Diurnal
What is being tested?: Diurnal variation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 11 Oct 2008to 1 Jan 2009
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Medically healthy
Normal sleep-wake pattern

Who cannot join

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

Show all 9Show fewer

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.

About this study

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

Conditions: Diurnal
Being tested: Diurnal variation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diurnal variationOther
Venous blood samples were obtained under standardized circumstances from 24 healthy young men every third hour through 24 hours, nine time points in total.

Study groups in NCT06166368
Study group	Role	What they receive
diurnal variations	Experimental	Venous blood samples were obtained under standardized conditions from 24 healthy young men every third hour through 24 hours Receives: Other: Diurnal variation

What is being measured

The primary outcome is the main question the study is designed to answer.

hematology parameters
Composite measurement of hematological measurements
Measured: 24 hours

Secondary outcomes (5)

Plasma Levels of Glucagon
Measured: 24 hours
Plasma levels of GLP-1
Measured: 24 hours
Plasma levels of GIP
Measured: 24 hours
Plasma levels of c-peptide
Measured: 24 hours
Plasma levels of glucose
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 20081 Jan 2009

First posted12 Dec 2023
Study start11 Oct 2008
Primary completion1 Jan 2009
Study completion1 Jan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for DiurnalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06166368
Sponsor's protocol ID: Diurnal variations
Acronym: DIURNAL
Status last verified: Dec 2023
First submitted: 4 Dec 2023
Last updated: 20 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Not allowed by ethical committe

Publications

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.
PubMed 21988588
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.
PubMed 22282468
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.
PubMed 22397709
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.
PubMed 24571735
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.
PubMed 26378655
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.
PubMed 27494182
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.
PubMed 31247945
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.
PubMed 32820681
Albrethsen J, Andreasen JK, Anton J, Sennels HP, Jorgensen HL, Hannibal J, Hermann D, Wewer Albrechtsen NJ. Measurements of plasma melatonin by rapid LC-MS/MS enables insight into diurnal variation in healthy humans. Scand J Clin Lab Invest. 2026;86(3):306-312. doi: 10.1080/00365513.2026.2660758. Epub 2026 Apr 20.
PubMed 42008634
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.
PubMed 38481208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Recruiting
NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment
Sleep Disorder, Circadian Dysregulation

All Diurnal trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: the Bispebjerg Study of Diurnal Variations
ClinicalTrials.gov ID: NCT06166368
Acronym / sponsor ID: DIURNAL / Diurnal variations
Conditions: Diurnal
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Bispebjerg HospitalUniversity, hospital or other
Collaborators: University of Copenhagen
Study start: 11 Oct 2008 (actual)
Primary completion: 1 Jan 2009 (actual)
Study completion: 1 Jan 2009 (actual)
First posted: 12 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
diurnal variations	Experimental	Other: Diurnal variationVenous blood samples were obtained under standardized conditions from 24 healthy young men every third hour through 24 hours

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Medically healthy
Normal sleep-wake pattern

Key exclusion criteria (9 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diurnal variationVenous blood samples were obtained under standardized circumstances from 24 healthy young men every third hour through 24 hours, nine time points in total.	Other	diurnal variations

Primary outcome

hematology parameters
Time frame: 24 hours
Composite measurement of hematological measurements

5 secondary outcomes

Plasma Levels of Glucagon
Time frame: 24 hours
Plasma levels of GLP-1
Time frame: 24 hours
Plasma levels of GIP
Time frame: 24 hours
Plasma levels of c-peptide
Time frame: 24 hours
Plasma levels of glucose
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
Background: PubMed 21988588Sennels 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.
Background: PubMed 22282468Goetze 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.
Background: PubMed 22397709Sennels 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.
Background: PubMed 24571735Timm 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.
Background: PubMed 26378655Sennels 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.
Background: PubMed 27494182Heegaard 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.
Background: PubMed 31247945Schroor 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.
Background: PubMed 32820681Rehfeld 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.
Derived from this study: PubMed 42008634Albrethsen J, Andreasen JK, Anton J, Sennels HP, Jorgensen HL, Hannibal J, Hermann D, Wewer Albrechtsen NJ. Measurements of plasma melatonin by rapid LC-MS/MS enables insight into diurnal variation in healthy humans. Scand J Clin Lab Invest. 2026;86(3):306-312. doi: 10.1080/00365513.2026.2660758. Epub 2026 Apr 20.
Derived from this study: PubMed 38481208Zilstorff 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.
Individual participant dataSharing planned: No. Not allowed by ethical committe

Related trials for Diurnal

RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Recruiting
NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment
Sleep Disorder, Circadian Dysregulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henriette P Sennels, MD PhD principal investigator

Bispebjerg Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Diurnal variation in people with Diurnal, run by Bispebjerg Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hematology parameters (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166368, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.