the Bispebjerg Study of Diurnal Variations (DIURNAL)

December 13, 2023 updated by: Henriette P. Sennels, Bispebjerg Hospital
To evaluate the influence of time of day on the circulating concentrations of various biochemical markers in healthy men

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diurnal variations
Venous blood samples were obtained under standardized conditions from 24 healthy young men every third hour through 24 hours
Other: Diurnal variation
Venous blood samples were obtained under standardized circumstances from 24 healthy young men every third hour through 24 hours, nine time points in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematology parameters
Time Frame: 24 hours
Composite measurement of hematological measurements
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Henriette P Sennels, MD PhD, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Diurnal variations

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not allowed by ethical committe

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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