drugset / Trial / NCT05919992

The Role of Glucocorticoids to Maintain Energy Homeostasis During Starvation (Gluco-Starve)

NCT05919992

Phase 0 Completed 24 enrolled Eleonora Seelig
RandomizedCrossoverDouble-blindPrevention

Summary

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.

Timeline

Start
2023-05-15
Primary completion
2024-07-25
Completion
2024-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 19.9 mg Subcutaneous
Subject Metyrapone Small molecule 3000 mg Oral