CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning (CIRCLE)

University of Aarhus

Status: Completed

Conditions: Healthy

Treatments: Drug: Prednisolone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06035081

1-10-72-83-22

Details and patient eligibility

About

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 hypotheses are:

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

Enrollment: 10 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male sex
• BMI 20-30 kg/m2
• Written informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Prednisolone first, then placebo

Experimental group

Description:

Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days

Treatment:

Other: Placebo

Drug: Prednisolone

Placebo first, then prednisolone

Experimental group

Description:

Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days.

Treatment:

Other: Placebo

Drug: Prednisolone