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

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.

Conditions

• Sleep Restriction

Interventions

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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  lead OTHER

Principal Investigators

• Peter Liu, MD, PhD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-09

Primary Completion

2022-07-24

Completion

2026-06-24

FDA Drug

Yes

Countries

• United States

Study Locations