Status:
COMPLETED
Hormonal Mechanisms of Sleep Restriction
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Insulin Resistance
Eligibility:
MALE
22-45 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
Screening Visits * To see if you are able to take part in this study, you will first have an outpatient visit at the CTRC (Clinical and Translational Research Center). This visit will take about 90 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02256865
Start Date
October 1 2014
End Date
October 1 2023
Last Update
September 11 2025
Active Locations (1)
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1
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90509