NCT03142893

Hormonal Mechanisms of Sleep Restriction - Axis Study

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peter y. Liu · Academic / Other
• Sex: Male
• Age: 22 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Detailed description

Sleep restriction increases evening cortisol and decreases testosterone. These are the main catabolic and anabolic hormones in men, respectively. This catabolic-anabolic imbalance likely leads to metabolic and reproductive ill-health. The hypothalamic-pituitary-end organ (adrenal or testis) mechanisms that must underpin these changes are unknown. This study will administer drugs to clamp the function of each of these nodes to determine the regulatory changes that have occurred with sleep restriction. Even though the study is randomized order in design, the main comparison is before and after sleep restriction under each of these clamp conditions. Participants are admitted to the chronobiology laboratory where they are given 1 night of 10 hours sleep opportunity, followed by 4 nights of 4 hours sleep opportunity. Up to 80 participants (assuming twenty different participant for each of the 4 clamp conditions) can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 20 participants may be required. Urn randomization will be used to ensure that 20 different participants are involved in each of the 4 conditions.

Conditions

• Sleep Restriction

Interventions

Type	Name	Description
DRUG	Ketoconazole Pill	Ketoconazole pill is taken 4 times per Inpatient Stay
DRUG	Ganirelix	Ganirelix subcutaneous injection is administered twice per Inpatient Stay
DRUG	Dexamethasone	Dexamethasone Pills is taken twice per Inpatient Stay
DRUG	Dexamethasone Injection	Dexamethasone IV injection is given twice per Inpatient Stay
DRUG	Cosyntropin Injectable Product	cosyntropin injection is given twice per Inpatient Stay
DRUG	Recombinant Human Luteinizing Hormone	Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit
DRUG	Hydrocortisone Injection	Hydrocortisone IV push is given twice per Inpatient Visit
DRUG	Gonadorelin	Gonadorelin IV injection is given twice per Inpatient Stay
DRUG	Corticorelin	Corticorelin IV injection is given twice per Inpatient Stay
DRUG	Placebo oral capsule	Placebo for ketoconazole are given 4 times per Inpatient Stay
DRUG	Saline Solution	Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per Inpatient Stay
DRUG	Saline Solution for Injection	Saline Solution (placebo) for ganirelix subcutaneous injection

Timeline

• Start date: 2017-05-08
• Primary completion: 2020-10-30
• Completion: 2026-06-30
• First posted: 2017-05-08
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study