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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

Quick Stats
Studies 172
Trials 37
Active Not Recruiting EARLY PHASE1 INTERVENTIONAL NCT04037605

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Average Blood Cortisol Concentration
TimeFrame: 5 days
Description: Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.
Measure: Average Blood Testosterone Concentration
TimeFrame: 5 days
Description: Testosterone is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.

Trial Information

NCT ID

NCT04037605

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

EARLY PHASE1

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Last Updated

December 15, 2025