Status:
COMPLETED
CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
The aim of this project is to study the effects of exogenous glucocorticoid exposure on substrate metabolism, energy expenditure and correlates of circadian rhythmicity in healthy adults. The hypothes...
Eligibility Criteria
Inclusion
- Male sex
- BMI 20-30 kg/m2
- Written informed consent
Exclusion
- Any chronic disease requiring daily medication excluding atopic skin or hay fever
- Alcohol consumption \>21 units per week
- Strong CYP3A4 inhibitors or inducers
- Use of glucocorticoid (GC) formulations: Inhaled corticosteroids, intra-articular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area
- Permitted glucocorticoid formulations: eye-drops, nasal spray, GC creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only
- Shift work
- Severe claustrophobia
- Use of melatonin
- Previous diagnosis of a sleep disorder
- Known severe sleep apnea (\>30 respiration breaks/hour over 10 seconds)
- Deemed unable to complete the study safely by investigator
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06035081
Start Date
September 15 2023
End Date
December 1 2024
Last Update
April 4 2025
Active Locations (1)
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1
Department of Endocrinology and Internal Medicine
Aarhus, State, Denmark, 8200