Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum… (NCT06556277) | Clinical Trial Compass
CompletedNot Applicable
Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake
Switzerland23 participantsStarted 2024-09-01
Plain-language summary
The investigator aim to understand whether food-induced glucocorticoids influence fat mass in overweight and obese people.
In a randomized, cross-over study, 23 overweight and obese volunteers will receive a block and replace therapy that mimics physiological glucocorticoid (GC) rhythm (metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy food-induced GC peak will be suppressed. Metabolic and immunological parameters will be compared to reveal the effects of GCs during excessive overfeeding, particularly to understand changes in body fat.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
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:
* Males aged 18 to 50 years
* BMI≥ 25 kg/m² with a stable weight within past three months before study initiation
Exclusion Criteria:
* Any severe acute or chronic disease, including diabetes mellitus type 2
* Intake of GLP-1 agonists or hormone therapy
* Hypercortisolism
* Casual smoking (more than 6 cigarettes per day)
* Frequent, heavy alcohol consumption (more than 30g/day)
* Frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day)
* Regular physical exercise (more than 4hrs per week)
* Shift work
* Participation in an investigational drug trial within the past two months
* Intake of any steroid-containing drugs, including topical steroids and inhalers, within 4 weeks of the study initiation
* Known allergy to metyrapone
* Inability or unwillingness to provide informed consent
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.