drugset / Trial / NCT07494084

Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance

NCT07494084

RandomizedParallel-groupDouble-blindDiagnostic

Summary

The purpose of this study is to examine the impact of timed cortisol release or differently timed cortisol rhythms on insulin resistance in both men and women undergoing sleep restriction. Chronic sleep loss is highly prevalent, affecting 1 in 3 adults in the US. Chronic sleep loss causes stress which induces insulin resistance and leads to obesity and type 2 diabetes. Many factors contribute to sleep loss including shift work, environmental disturbances, sleep/circadian disorders and comorbid medical and mental health conditions. Sleep loss increases the stress hormone cortisol in the evening and decreases daytime testosterone. Examining these hormones in a controlled laboratory environment under different sleep schedules may help researchers find solutions for adults experiencing negative health consequences related to chronic sleep loss.

Timeline

Start
2026-07-01
Primary completion
2029-03
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrocortisone Other / unclassified 0.5 mg Subcutaneous
Comparator Hydrocortisone Other / unclassified 2.3 mg Subcutaneous
Comparator Hydrocortisone Other / unclassified 4 mg Subcutaneous
Comparator Metyrapone Small molecule 500 mg Oral
Comparator Dextrose Unknown 300 mg/kg Intravenous
Comparator Insulin Protein / enzyme biologic 0.03 iu/kg Intravenous