NCT04037605

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Academic / Other
• Sex: All
• Age: 60 Years – 80 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 and 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 and its consequences are major public health problems, especially in older adults. Among the more severe physiological sequelae of sleep restriction is the development of insulin resistance. The mechanisms by which sleep restriction leads to increased insulin resistance are unknown, especially in vulnerable older adults; such research informs development of targeted interventions against the sleep loss/insulin resistance link. 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 40 participants can be enrolled. However, participants will be allowed an opportunity to be randomized to all 4 conditions so that as few as 10 participants may be required. We anticipate 5 men and 5 women will be enrolled assuming each undergoes all 4 clamp conditions.

Conditions

• Sleep Restriction

Interventions

Type	Name	Description
DRUG	Ketoconazole Pill (also known as nizoral)	Ketoconazole pill is taken 4 times per inpatient visit
DRUG	Ganirelix	Ganirelix subcutaneous injection is administered twice per inpatient visit
DRUG	Dexamethasone Pill	Dexamethasone pills is taken twice per inpatient visit
DRUG	Dexamethasone injection	Dexamethasone IV injection is given twice per inpatient visit
DRUG	Cosyntropin Injectable Product	Cosyntropin injection is given twice per inpatient visit
DRUG	Recombinant Human Luteinizing Hormone (also known as luveris)	Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit
DRUG	Hydrocortisone Injection (also known as solu-cortef)	Hydrocortisone IV push is given twice per inpatient visit
DRUG	Gonadorelin (also known as Lutrepulse)	Gonadorelin IV injection is given twice per inpatient visit
DRUG	Corticorelin (also known as Acthrel)	Corticorelin IV injection is given twice per inpatient visit
DRUG	Placebo oral tablet	Placebo for Ketoconazole are given 4 times per inpatient visit
DRUG	Saline Solution	Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit
DRUG	Saline solution for injection	Saline Solution (placebo) for ganirelix subcutaneous injection

Timeline

• Start date: 2020-02-09
• Primary completion: 2022-07-24
• Completion: 2026-06-24
• First posted: 2019-07-30
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study