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

NCT06035081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-04

No results posted yet for this study

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 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

Conditions

  • Healthy

Interventions

DRUG

Prednisolone

see arm description

OTHER

Placebo

Placebo similar to prednisolone

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens Otto L Jørgensen, Professor · Aarhus University Hospital

  • Simon B Hansen, MD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-04-13
Completion
2024-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035081 on ClinicalTrials.gov