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

• Status: Recruiting
• Trial end date: 2023-07-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: BB 1101; Corticotropin-Releasing Hormone; Cosyntropin; Dexamethasone; Dexamethasone acetate; Ganirelix; Hormones; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Ketoconazole; Pharmaceutical Solutions; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Men or postmenopausal women aged 60-80 years

• Willingness to provide written informed consent

• Stable weight over preceding 6 weeks

• Body Mass index (BMI) 22-28 kg/m2

• Physically and psychologically healthy

• Good habitual sleep with regular bedtimes

• Neither extreme morning- nor extreme evening-type using Horne-Ostberg Morningness-Eveningness criteria

Exclusion Criteria:

• Medications that interfere with the adrenal or gonadal axis will be excluded

• 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

• Mini- mental state examination (MMSE) < 27