NCT06035081

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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

September 6, 2023

Last Update Submit

April 1, 2025

Conditions

Healthy

Keywords

glucocorticoidscircadian rhythmmetabolism

Outcome Measures

Primary Outcomes (4)

  • Change in Sleeping RER

    Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone

    Study day 1 and 2 (7 weeks apart)

  • Change in TEE

    Change in Total Energy Expenditure between placebo and prednisolone

    Study day 1 and 2 (7 weeks apart)

  • Change in REE

    Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening

    Study day 1 and 2 (7 weeks apart)

  • Change in RER from fasting to feeding

    Change in respiratory exchange ratio (RER) after standard meal between placebo and prednisolone and morning/evening

    Study day 1 and 2 (7 weeks apart)

Secondary Outcomes (33)

  • Change in PAEE

    Study day 1 and 2 (7 weeks apart)

  • Change in SEE

    Study day 1 and 2 (7 weeks apart)

  • Change in DIT

    Study day 1 and 2 (7 weeks apart)

  • Change in clock gene mRNA levels leukocytes

    Study day 1 and 2 (7 weeks apart)

  • Change in clock gene mRNA levels adipose tissue

    Study day 1 and 2 (7 weeks apart)

  • +28 more secondary outcomes

Study Arms (2)

Prednisolone first, then placebo

EXPERIMENTAL

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

Drug: PrednisoloneOther: Placebo

Placebo first, then prednisolone

EXPERIMENTAL

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

Drug: PrednisoloneOther: Placebo

Interventions

PrednisoloneDRUG

see arm description

Placebo first, then prednisolonePrednisolone first, then placebo
PlaceboOTHER

Placebo similar to prednisolone

Placebo first, then prednisolonePrednisolone first, then placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus, State, 8200, Denmark

Location

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jens Otto L Jørgensen, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

  • Simon B Hansen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

September 15, 2023

Primary Completion

April 13, 2024

Study Completion

December 1, 2024

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)