Summary

for males ages 22-45 (full criteria)
healthy people welcome
at UCLA
study started
estimated completion
Peter Liu(ucla)

Description

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.

Details

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.

Keywords

Sleep Restriction testosterone cortisol Ketoconazole Dexamethasone Dexamethasone acetate Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Pharmaceutical Solutions Hormones Cosyntropin Prolactin Release-Inhibiting Factors Corticotropin-Releasing Hormone BB 1101 Ganirelix Ketoconazole Pill Dexamethasone Injection Cosyntropin Injectable Product Recombinant Human Luteinizing Hormone Hydrocortisone Injection Gonadorelin Corticorelin Saline Solution Saline Solution for Injection

Eligibility

You can join if…

Open to males ages 22-45

  • Men aged 22-45 years
  • Willingness to provide written informed consent
  • Stable weight over preceding 6 weeks
  • Body Mass index (BMI) 20-28 kg/m2

You CAN'T join if...

  • Unable or unwilling to provide IRB (Internal Review Board)-approved informed consent
  • Clinical disorders and/or illnesses
  • Current medical or drug treatment, as assessed by questionnaire
  • History of brain injury or of learning disability - Vision or hearing impairment unless corrected back to normal
  • Anemia (Hct <38%)
  • History of psychiatric illness
  • Clinically significant abnormalities in blood and urine, and free of traces of drugs
  • Other endocrine abnormalities including hypothyroidism or adrenal failure; primary gonadal disease as indicated by serum LH (luteinizing hormone) or FSH (follicle stimulating hormone) concentration >10 or >15 IU/L, respectively, hyperprolactinemia indicated by prolactin >25ug/L
  • Type 2 Diabetes (HgbA1C)
  • Current smoker
  • Recent or concurrent drug or alcohol abuse
  • Blood donation in previous eight weeks
  • Travel across time zones within one month of entering the study
  • Sleep or circadian disorder
  • Shift work within three months of entering the study
  • Irregular bedtimes (not between 6 and 10 hours in duration)
  • Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, Hx or Suspicion of cancer of the prostate gland or PSA (prostate-specific antigen) >4ng/ml
  • Previous adverse reaction to sleep deprivation or any of the drugs to be administered
  • Concurrent participation in another research study

Location

  • Los Angeles Biomedical Research Institute accepting new patients
    Torrance California 90509 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ID
NCT03142893
Phase
Phase 1
Study Type
Interventional
Last Updated