- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03142893
Hormonal Mechanisms of Sleep Restriction - Axis Study
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Gonadorelin
- Drug: Corticorelin
- Drug: Placebo oral capsule
- Drug: Saline Solution
- Drug: Saline Solution for Injection
- Drug: Ganirelix
- Drug: Dexamethasone Injection
- Drug: Ketoconazole Pill
- Drug: Hydrocortisone Injection
- Drug: Dexamethasone
- Drug: Cosyntropin Injectable Product
- Drug: Recombinant Human Luteinizing Hormone
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Torrance, California, United States, 90509
- Los Angeles Biomedical Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Condition
8 am - Saline Solution for Injection 10 am - Placebo oral capsule 1 pm - Saline Solution for Injection 4 pm - Placebo oral capsule & start hourly blood sampling 7 pm - Gonadorelin (GnRH) and Corticorelin (CRH) injections 9 pm - Saline Solution for Injection & last blood sample |
Gonadorelin IV injection is given twice per Inpatient Stay
Other Names:
Corticorelin IV injection is given twice per Inpatient Stay
Other Names:
Placebo for ketoconazole are given 4 times per Inpatient Stay
Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per Inpatient Stay
Saline Solution (placebo) for ganirelix subcutaneous injection
|
Experimental: Hypothalamic Condition
8 am - Ganirelix 10 am - Placebo oral capsule 1 pm - Dexamethasone injection 4 pm - Placebo oral capsule and start of hourly blood sampling 7 pm - GnRH and CRH injections 9 pm - Saline Solution for Injection and last sample of blood taken |
Gonadorelin IV injection is given twice per Inpatient Stay
Other Names:
Corticorelin IV injection is given twice per Inpatient Stay
Other Names:
Placebo for ketoconazole are given 4 times per Inpatient Stay
Saline Solution (placebo) for ganirelix subcutaneous injection
Ganirelix subcutaneous injection is administered twice per Inpatient Stay
Dexamethasone IV injection is given twice per Inpatient Stay
|
Experimental: Pituitary Condition
8am - Saline Solution for Injection 10am - Ketoconazole Pill 1pm - Saline Solution for Injection 4pm - Ketoconazole Pill & start of hourly blood sampling 7pm - GnRH and CRH 9pm - Hydrocortisone Injection & last blood sample |
Gonadorelin IV injection is given twice per Inpatient Stay
Other Names:
Corticorelin IV injection is given twice per Inpatient Stay
Other Names:
Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per Inpatient Stay
Ketoconazole pill is taken 4 times per Inpatient Stay
Other Names:
Hydrocortisone IV push is given twice per Inpatient Visit
Other Names:
|
Experimental: Adrenal/Testis Condition
10pm - Ganirelix Injection & Dexamethasone Pills (night before) 8am - start of hourly blood sampling 10am - Dexamethasone Pills 11am - last hourly blood sample taken 11:30am - start of blood sampling every 10 minutes 1pm - Recombinant Human Luteinizing Hormone (rhLH) Injection 3pm - rhLH Injection 5pm - rhLH Injection 5pm - Cosyntropin Injectable product 7pm - GnRH and CRH Injections 9pm - last blood sample taken |
Gonadorelin IV injection is given twice per Inpatient Stay
Other Names:
Corticorelin IV injection is given twice per Inpatient Stay
Other Names:
Ganirelix subcutaneous injection is administered twice per Inpatient Stay
Dexamethasone Pills is taken twice per Inpatient Stay
cosyntropin injection is given twice per Inpatient Stay
Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Blood Cortisol Concentration
Time Frame: 5 days
|
Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
The average cortisol is the parameter of interest.
|
5 days
|
Average Blood Testosterone Concentration
Time Frame: 5 days
|
Testosterone is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
The average cortisol is the parameter of interest.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Blood Cortisol Concentration
Time Frame: 5 days
|
This is the single maximal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
|
5 days
|
Peak Blood Testosterone Concentration
Time Frame: 5 days
|
This is the single maximal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
|
5 days
|
Trough Blood Cortisol Concentration
Time Frame: 5 days
|
This is the single minimal blood cortisol concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
|
5 days
|
Trough Blood Testosterone Concentration
Time Frame: 5 days
|
This is the single minimal blood testosterone concentration that is measured during the entire 5 hour period, at the beginning and at the end of 4 nights of sleep restriction.
|
5 days
|
Reaction time on Psychomotor Vigilance Task
Time Frame: 5 days
|
This is measured by lapses in attention.
As the person becomes more sleepy, there are more lapses (reaction time >500 ms), at the beginning and at the end of 4 nights of sleep restriction.
|
5 days
|
Karolinska Sleepiness Scale
Time Frame: 5 days
|
Measures how sleepy participants are using a scale of 1 (extremely alert) through 9.
This scale will be used to assess changes in sleepiness throughout the day and through 4 nights of sleep restriction.
|
5 days
|
Two card gambling task
Time Frame: 5 days
|
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects participants' decision making.
The end point is discriminability index, d'.
|
5 days
|
Modified Sternberg working memory test
Time Frame: 5 days
|
Computerized neurobehavioral testing to determine how 4 nights of sleep restriction affects reaction time and accuracy.
|
5 days
|
Caloric Intake
Time Frame: 5 days
|
The food given to participants is weighed.
The amount that is not consumed is also weighed.
The difference in weight is the amount of calories consumed.
|
5 days
|
Hunger Scale
Time Frame: 5 days
|
Hunger scale using Flint visual analogue scale to assess how 4 nights of sleep restriction affects participants' appetite.
|
5 days
|
Food Cravings
Time Frame: 5 days
|
Food cravings is measured using Food Cravings Index scale to assess which food groups participants have cravings for and how their cravings change during 4 nights of sleep restriction.
|
5 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter Liu, MD, PhD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Pharmaceutical Solutions
- Hormones
- Ketoconazole
- Hydrocortisone
- Hydrocortisone hemisuccinate
- Ganirelix
- Prolactin Release-Inhibiting Factors
- Cosyntropin
Other Study ID Numbers
- 30068-01A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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