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Clinical Trials/NCT06166368
NCT06166368CompletedNot Applicable

the Bispebjerg Study of Diurnal Variations

Bispebjerg Hospital0 sites24 target enrollmentStarted: October 11, 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Primary Endpoint
hematology parameters

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

hematology parameters

Time Frame: 24 hours

Composite measurement of hematological measurements

Secondary Outcomes

  • Plasma levels of GIP(24 hours)
  • Plasma Levels of Glucagon(24 hours)
  • Plasma levels of GLP-1(24 hours)
  • Plasma levels of c-peptide(24 hours)
  • Plasma levels of glucose(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henriette P. Sennels

MD PhD.

Bispebjerg Hospital

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the Bispebjerg Study of Diurnal Variations | Clinical Trial