Hormonal Mechanisms of Sleep Restriction

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to study the effects of sleep restriction on the production of two hormones, cortisol and testosterone. The investigators aim to show that changing these hormones leads to insulin resistance, which is an important cause of type 2 diabetes mellitus. The investigators may also study the effect of sleep restriction on your food intake and cravings, mood, inflammation, metabolism (including bone), and other hormones. Inflammation is your body's response to stress and injury. Bone metabolism is a process of how your body regenerates (renews) new bone cells and removes old bone cells. Hormones are natural substances (materials) that are produced in the body and that influences (effects) the way the body grows or develops.

• 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: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Ketoconazole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable or unwilling to provide IRB-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 or FSH 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 >4ng/ml

• Previous adverse reaction to sleep deprivation or any of the drugs to be administered

• Concurrent participation in another research study