HealthyCIRCLENCT06035081
CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning
A study testing Prednisolone in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- BMI 20-30 kg/m2
- Written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Medicine
Aarhus, State, 8200
About this study
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
- Being tested
- Prednisolone, Placebo
- Keywords
- glucocorticoids, circadian rhythm, metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
see arm description
PlaceboOther
Placebo similar to prednisolone
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone first, then placebo | Experimental | Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days Receives: Drug: Prednisolone; Other: Placebo |
| Placebo first, then prednisolone | Experimental | Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days. Receives: Drug: Prednisolone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleeping RER
Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone
Measured: Study day 1 and 2 (7 weeks apart)
Change in TEE
Change in Total Energy Expenditure between placebo and prednisolone
Measured: Study day 1 and 2 (7 weeks apart)
Change in REE
Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening
Measured: 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
Measured: Study day 1 and 2 (7 weeks apart)
Secondary outcomes (33)
Change in PAEE
Change in Physical Activity related Energy Expenditure (PAEE) between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in SEE
Change in Sleeping Energy Expenditure (PAEE) between placebo and prednisolone
Measured: Study day 1 and 2 (7 weeks apart)
Change in DIT
Change in diet-induced thermogenesis between placebo and prednisolone and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in clock gene mRNA levels leukocytes
Change in mRNA expression levels in blood leukocytes between placebo and prednisolone and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in clock gene mRNA levels adipose tissue
Change in mRNA expression levels in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in clock gene mRNA levels skeletal muscle
Change in mRNA expression levels in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in appetite
Measured by numerical rating scale on parameters hunger, fullness, satiety, desire and prospective consumption with values 1 (not at all) to 10 (maximally present) before and after ad libitum meal and standard meal, and between placebo and prednisolone and morning/evening. The scale is adapted from PMID: 20122136
Measured: Study day 1 and 2 (7 weeks apart)
Change in ad libitum food intake
Measured by caloric intake between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in food intake at home
Measured by dietary registration during prednisolone and placebo
Measured: Intervention period 1 and 2 (7 weeks apart)
Change in fasting lipid oxidation rates
Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in lipid oxidation rates from fasting to fed
Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in glucose oxidation rates from fasting to fed
Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in fasting glucose oxidation rates
Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in fasting protein oxidation rates
Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in protein oxidation rates from fasting to fed
Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in ghrelin levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in LEAP-2 levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in GLP-1 levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in GIP levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in Glucose levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in Insulin levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in Glucagon levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in Gastrin levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in CCK levels
Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in cortisol levels
Measured successively over 24 hours in serum during study days
Measured: Study day 1 and 2 (7 weeks apart)
Change in FAP cells in skeletal muscle
Fibro-adipogenic progenitor cells levels and characteristics in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in FAP cells in adipose tissue
Fibro-adipogenic progenitor cells levels and characteristics in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
Measured: Study day 1 and 2 (7 weeks apart)
Change in physical activity levels
Measured by actigraph during study periods
Measured: Intervention period 1 and 2 (7 weeks apart)
Change in IPAQ-7
Measured by Internation Physical Activity Questionnaire
Measured: Intervention period 1 and 2 (7 weeks apart)
Change in sleep quality (measured)
Measured by actigraph during study periods
Measured: Intervention period 1 and 2 (7 weeks apart)
Change in sleep quality (reported)
Measured by Pittsburgh Sleep Quality Index questionnaire
Measured: Intervention period 1 and 2 (7 weeks apart)
Change in sleep quality
Measured by polysomnography
Measured: Study day 1 and 2 (7 weeks apart)
Change in HADS
Measured by Hospital Anxiety and Depression Scale (HADS), a 14-question instrument with 7 questions measuring anxiety and 7 measuring depression. Each is scored between 0 (no impairment) and 3 (severe impairment)
Measured: Intervention period 1 and 2 (7 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Sep 2023
- Primary completion13 Apr 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Otto L Jørgensen, Professor, Study director, Aarhus University HospitalSimon B Hansen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035081
- Sponsor's protocol ID
- 1-10-72-83-22
- Acronym
- CIRCLE
- Status last verified
- Apr 2025
- First submitted
- 6 Sep 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning
- ClinicalTrials.gov ID
- NCT06035081
- Acronym / sponsor ID
- CIRCLE / 1-10-72-83-22
- Conditions
- Healthy
- Keywords
- glucocorticoids, circadian rhythm, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone first, then placebo | Experimental | Drug: Prednisolone, Other: PlaceboPrednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days |
| Placebo first, then prednisolone | Experimental | Drug: Prednisolone, Other: PlaceboPlacebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male sex
- BMI 20-30 kg/m2
- Written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolonesee arm description | Drug | Placebo first, then prednisolone, Prednisolone first, then placebo |
| PlaceboPlacebo similar to prednisolone | Other | Placebo first, then prednisolone, Prednisolone first, then placebo |
Primary outcome
Change in Sleeping RER
Time frame: Study day 1 and 2 (7 weeks apart)
Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone
Change in TEE
Time frame: Study day 1 and 2 (7 weeks apart)
Change in Total Energy Expenditure between placebo and prednisolone
Change in REE
Time frame: Study day 1 and 2 (7 weeks apart)
Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening
Change in RER from fasting to feeding
Time frame: Study day 1 and 2 (7 weeks apart)
Change in respiratory exchange ratio (RER) after standard meal between placebo and prednisolone and morning/evening
33 secondary outcomes
Change in PAEE
Time frame: Study day 1 and 2 (7 weeks apart)
Change in SEE
Time frame: Study day 1 and 2 (7 weeks apart)
Change in DIT
Time frame: Study day 1 and 2 (7 weeks apart)
Change in clock gene mRNA levels leukocytes
Time frame: Study day 1 and 2 (7 weeks apart)
Change in clock gene mRNA levels adipose tissue
Time frame: Study day 1 and 2 (7 weeks apart)
Change in clock gene mRNA levels skeletal muscle
Time frame: Study day 1 and 2 (7 weeks apart)
Change in appetite
Time frame: Study day 1 and 2 (7 weeks apart)
Change in ad libitum food intake
Time frame: Study day 1 and 2 (7 weeks apart)
Change in food intake at home
Time frame: Intervention period 1 and 2 (7 weeks apart)
Change in fasting lipid oxidation rates
Time frame: Study day 1 and 2 (7 weeks apart)
Change in lipid oxidation rates from fasting to fed
Time frame: Study day 1 and 2 (7 weeks apart)
Change in glucose oxidation rates from fasting to fed
Time frame: Study day 1 and 2 (7 weeks apart)
Change in fasting glucose oxidation rates
Time frame: Study day 1 and 2 (7 weeks apart)
Change in fasting protein oxidation rates
Time frame: Study day 1 and 2 (7 weeks apart)
Change in protein oxidation rates from fasting to fed
Time frame: Study day 1 and 2 (7 weeks apart)
Change in ghrelin levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in LEAP-2 levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in GLP-1 levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in GIP levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in Glucose levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in Insulin levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in Glucagon levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in Gastrin levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in CCK levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in cortisol levels
Time frame: Study day 1 and 2 (7 weeks apart)
Change in FAP cells in skeletal muscle
Time frame: Study day 1 and 2 (7 weeks apart)
Change in FAP cells in adipose tissue
Time frame: Study day 1 and 2 (7 weeks apart)
Change in physical activity levels
Time frame: Intervention period 1 and 2 (7 weeks apart)
Change in IPAQ-7
Time frame: Intervention period 1 and 2 (7 weeks apart)
Change in sleep quality (measured)
Time frame: Intervention period 1 and 2 (7 weeks apart)
Change in sleep quality (reported)
Time frame: Intervention period 1 and 2 (7 weeks apart)
Change in sleep quality
Time frame: Study day 1 and 2 (7 weeks apart)
Change in HADS
Time frame: Intervention period 1 and 2 (7 weeks apart)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Otto L Jørgensen, Professor study director
Aarhus University Hospital
Simon B Hansen, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone in people with Healthy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleeping RER (time frame: Study day 1 and 2 (7 weeks apart)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.