Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Me… (NCT03949361) | Clinical Trial Compass
CompletedNot Applicable
Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
Switzerland7 participantsStarted 2019-06-01
Plain-language summary
The aim of the study is to investigate whether treatment with glucocorticoids leads to a change in heat production of the human body at mild cold conditions.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Planned therapy with at least 7.5 mg prednisone equivalent per day or higher for more than 28 days (group A)
* Planned weaning off glucocorticoid therapy which lasted al least 28 days with a dosage of at least 7.5 mg prednisone (group B)
* BMI 19-30 kg/m2
* Informed Consent as documented by signature
Exclusion Criteria:
* Insufficient thyroid hormone substitution in case of hypothyroidism
* Uncontrolled diabetes mellitus (HbA1c \>7.5%)
* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
* Known hypersensitivity to cold, e.g. primary or secondary Raynaud's Syndrome
* Known or suspected non-compliance
* Abuse of alcohol or illicit drugs
* Claustrophobia
* Women who are pregnant or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc of the participant
* Previous enrolment into the current study
* Enrolment into another study using ionizing radiation within the previous 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cold-induced thermogenesis (CIT) under glucocorticoids
Timeframe: Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)