CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning
NCT ID: NCT06035081
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2023-09-15
2024-12-01
Brief Summary
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Short-term high dose glucocorticoid exposure in healthy subjects disrupts:
* The inherent circadian pattern of the respiratory exchange ratio and REE
* Sleep quality, appetite and food intake
* Clock gene expression and function in adipose tissue, skeletal muscle and blood leukocytes
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Prednisolone first, then placebo
Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days
Prednisolone
see arm description
Placebo
Placebo similar to prednisolone
Placebo first, then prednisolone
Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days.
Prednisolone
see arm description
Placebo
Placebo similar to prednisolone
Interventions
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Prednisolone
see arm description
Placebo
Placebo similar to prednisolone
Eligibility Criteria
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Inclusion Criteria
* BMI 20-30 kg/m2
* Written informed consent
Exclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Jens Otto L Jørgensen, Professor
Role: STUDY_DIRECTOR
Aarhus University Hospital
Simon B Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Department of Endocrinology and Internal Medicine
Aarhus, State, Denmark
Countries
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Other Identifiers
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1-10-72-83-22
Identifier Type: -
Identifier Source: org_study_id
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