Effects of glucocorticoids on fat mass during overeating in overweight individuals
Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake: a Double-blind, Randomized, Placebo-controlled, Cross-over Study
This study is testing if a treatment that mimics natural hormone patterns can help overweight people manage fat gain when they eat too much.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Basel-Stadt) |
| Trial ID | NCT06556277 on ClinicalTrials.gov |
What this trial studies
This study investigates how food-induced glucocorticoids affect fat mass in overweight and obese individuals during periods of excessive calorie intake. In a randomized, cross-over design, 23 participants will receive either a treatment that mimics natural glucocorticoid rhythms or a placebo while undergoing two identical overfeeding phases. The treatment involves administering metyrapone and hydrocortisone to suppress glucocorticoid peaks induced by food intake. The study aims to compare metabolic, autonomic, and immunological parameters to understand the role of glucocorticoids in obesity.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 50 years with a BMI of 25 kg/m² or higher and stable weight for the past three months.
Not a fit: Patients with severe chronic diseases, diabetes, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for managing obesity by targeting glucocorticoid levels.
How similar studies have performed: While the role of glucocorticoids in obesity has been studied, this specific approach of manipulating glucocorticoid rhythms during overeating is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel, Basel-Stadt
- University Hospital Basel — Basel, Basel-Stadt, Switzerland (Recruiting)
Study contacts
- Principal investigator: Eleonora Seelig, PD Dr.med. — Sponsor and principal investigator
- Study coordinator: Eleonora Seelig, PD Dr.med.
- Email: eleonora.seelig@usb.ch
- Phone: 0041 61 328 63 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.