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Hormonal Mechanisms of Sleep Restriction

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ClinicalTrials.gov Identifier: NCT02256865
Recruitment Status : Active, not recruiting
First Posted : October 6, 2014
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

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 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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: Ketoconazole Drug: Hydrocortisone Drug: Testosterone Drug: Placebo for ketoconazole Drug: Placebo for hydrocortisone Drug: Placebo for testosterone Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Hormonal Mechanisms of Sleep Restriction
Study Start Date : October 2014
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo and Drug Group 2
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
Drug: Ketoconazole
Ketoconazole is taken 4 times a day
Other Name: Nizoral

Drug: Hydrocortisone
Hydrocortisone is taken 3 times a day
Other Name: Cortef, Cortril, Hydrocortone

Drug: Testosterone
Testosterone gel is applied once a day
Other Name: AndroGel

Drug: Placebo for ketoconazole
Placebo for ketoconazole

Drug: Placebo for hydrocortisone
Placebo for hydrocortisone

Drug: Placebo for testosterone
Placebo for testosterone

Active Comparator: Drug and Placebo Group 1
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
Drug: Ketoconazole
Ketoconazole is taken 4 times a day
Other Name: Nizoral

Drug: Hydrocortisone
Hydrocortisone is taken 3 times a day
Other Name: Cortef, Cortril, Hydrocortone

Drug: Testosterone
Testosterone gel is applied once a day
Other Name: AndroGel

Drug: Placebo for ketoconazole
Placebo for ketoconazole

Drug: Placebo for hydrocortisone
Placebo for hydrocortisone

Drug: Placebo for testosterone
Placebo for testosterone




Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 3 years ]
    Insulin sensitivity determined by minimal model of a frequently sampled oral glucose tolerance test (OGTT).This method is extensively validated, and previously utilized by us.


Secondary Outcome Measures :
  1. Disposition index [ Time Frame: 3 years ]
    Disposition index (determined by minimal model of the same OGTT)

  2. C-peptide glucose dose-response [ Time Frame: 3 years ]
    C-peptide glucose dose-response (also calculated from the same OGTT)

  3. Lapses on Psychomotor Vigilance Task [ Time Frame: 3 years ]
    Measure of psychomotor performance

  4. Karolinska Sleepiness Scale [ Time Frame: 3 years ]
    Measures sleepiness

  5. Urinary Catecholamines [ Time Frame: 3 years ]
    Measures sympathetic/parasympathetic activity

  6. Heart Rate Variability [ Time Frame: 3 years ]
    Measures sympathetic/parasympathetic activity

  7. Free Fatty Acid Concentrations [ Time Frame: 3 years ]
    Measures potential mediator of insulin resistance

  8. Inflammatory marker panel [ Time Frame: 3 years ]
    blood interleukin-6, sTNFr2, IL1ra, CRP, NFkB concentrations

  9. Computerized cognitive testing [ Time Frame: 3 years ]
    Two card gambling task, modified Sternberg working memory task

  10. Bone turnover panel [ Time Frame: 3 years ]
    P1NP (bone formation marker) and NTX (bone resorption marker)

  11. Food cravings, [ Time Frame: 3 years ]
    Food Craving Index

  12. Assessment of mood states. [ Time Frame: 3 years ]
    Profile of Mood States (POMS)

  13. Food intake [ Time Frame: 3 years ]
    meal and snack consumption calculation

  14. Hunger measurement [ Time Frame: 3 years ]
    Flint visual analogue scale


Other Outcome Measures:
  1. Epigenetics [ Time Frame: 3 years ]
    Explorative study



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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256865


Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90509
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Peter Y Liu, MD PhD Los Angeles Biomedical Research Institute

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Data Analysis Plan available by request to PI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT02256865     History of Changes
Other Study ID Numbers: 30068-01
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Los Angeles Biomedical Research Institute:
Sleep Restriction
Insulin Resistance
Testosterone
Cortisol

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Ketoconazole
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Anti-Inflammatory Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists