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NCT05919992
The Role of Glucocorticoids to Maintain Energy Homeostasis During Starvation (Gluco-Starve)
EARLY_PHASE1 trial testing Metyrapone 250 mg Oral Tablets in Glucocorticoid Effect in 24 participants. Completed in 25 July 2024.
25 July 2024
Quick facts
| Lead sponsor | Eleonora Seelig |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 24 |
| Start date | 15 May 2023 |
| Primary completion | 25 July 2024 |
| Estimated completion | 25 July 2024 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Metyrapone 250 mg Oral Tablets — full drug profile →
- Hydrocortisone 19.9mg s.c., pulsatile with a flow rate of 10μl/s
- Placebo 250 mg Tablets
- Placebo (0,9% NaCl solution) — full drug profile →
Conditions studied
- Glucocorticoid Effect — all drugs for Glucocorticoid Effect →
Sponsor
Eleonora Seelig — full company profile →
Who can join
Adults 18 to 40, male only, with Glucocorticoid Effect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In a randomized, cross-over study, 20 healthy volunteers will receive a block and replace therapy that mimics physiological GC rhythm (metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical fasting periods with each treatment. With the block and replace therapy, fasting-induced GC peak will be suppressed. Metabolic and autonomic parameters will be compared to reveal whether GCs mediate the physiological adaptions to caloric restriction. Understanding acute effects of GCs upon caloric restriction is critical, since repetitive disruptions of GC secretion may become harmful in chronic conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05919992
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metyrapone 250 mg Oral Tablets
Trials testing the same drug.
- NCT07268222 — Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS) · Phase 4 · recruiting
- NCT05167084 — Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals · EARLY_PHASE1 · completed
Other Eleonora Seelig trials
Trials by the same sponsor.
- NCT06724692 — Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals · NA · completed
- NCT06556277 — Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake · NA · completed
- NCT05167084 — Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals · EARLY_PHASE1 · completed
- NCT04659915 — Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin · Phase 4 · completed
- NCT04482738 — Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05919992 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eleonora Seelig
- Last refreshed: 14 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05919992.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing