NCT02256865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2014

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

September 22, 2014

Last Update Submit

September 4, 2025

Conditions

Insulin Resistance

Keywords

Sleep RestrictionInsulin ResistanceTestosteroneCortisol

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    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.

    3 years

Secondary Outcomes (14)

  • Disposition index

    3 years

  • C-peptide glucose dose-response

    3 years

  • Lapses on Psychomotor Vigilance Task

    3 years

  • Karolinska Sleepiness Scale

    3 years

  • Urinary Catecholamines

    3 years

  • +9 more secondary outcomes

Other Outcomes (1)

  • Epigenetics

    3 years

Study Arms (2)

Placebo and Drug Group 2

PLACEBO COMPARATOR

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: KetoconazoleDrug: HydrocortisoneDrug: TestosteroneDrug: Placebo for ketoconazoleDrug: Placebo for hydrocortisoneDrug: Placebo for testosterone

Drug and Placebo Group 1

ACTIVE COMPARATOR

Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day

Drug: KetoconazoleDrug: HydrocortisoneDrug: TestosteroneDrug: Placebo for ketoconazoleDrug: Placebo for hydrocortisoneDrug: Placebo for testosterone

Interventions

KetoconazoleDRUG

Ketoconazole is taken 4 times a day

Also known as: Nizoral
Drug and Placebo Group 1Placebo and Drug Group 2
HydrocortisoneDRUG

Hydrocortisone is taken 3 times a day

Also known as: Cortef, Cortril, Hydrocortone
Drug and Placebo Group 1Placebo and Drug Group 2
TestosteroneDRUG

Testosterone gel is applied once a day

Also known as: AndroGel
Drug and Placebo Group 1Placebo and Drug Group 2
Placebo for ketoconazoleDRUG

Placebo for ketoconazole

Drug and Placebo Group 1Placebo and Drug Group 2
Placebo for hydrocortisoneDRUG

Placebo for hydrocortisone

Drug and Placebo Group 1Placebo and Drug Group 2
Placebo for testosteroneDRUG

Placebo for testosterone

Drug and Placebo Group 1Placebo and Drug Group 2

Eligibility Criteria

Age22 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90509, United States

Location

Related Publications (4)

  • O'Byrne NA, Yuen F, Niaz W, Liu PY. Sleep and the Testis. Curr Opin Endocr Metab Res. 2021 Jun;18:83-93. doi: 10.1016/j.coemr.2021.03.002. Epub 2021 Mar 11.

    PMID: 33937581BACKGROUND

  • O'Byrne NA, Yuen F, Butt WZ, Liu PY. Sleep and Circadian Regulation of Cortisol: A Short Review. Curr Opin Endocr Metab Res. 2021 Jun;18:178-186. doi: 10.1016/j.coemr.2021.03.011. Epub 2021 May 5.

    PMID: 35128146BACKGROUND

  • Liu PY, Lawrence-Sidebottom D, Piotrowska K, Zhang W, Iranmanesh A, Auchus RJ, Veldhuis JD, Van Dongen HPA. Clamping Cortisol and Testosterone Mitigates the Development of Insulin Resistance during Sleep Restriction in Men. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3436-e3448. doi: 10.1210/clinem/dgab375.

    PMID: 34043794RESULT

  • Zhang W, Piotrowska K, Chavoshan B, Wallace J, Liu PY. Sleep Duration Is Associated With Testis Size in Healthy Young Men. J Clin Sleep Med. 2018 Oct 15;14(10):1757-1764. doi: 10.5664/jcsm.7390.

    PMID: 30353813DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

KetoconazoleHydrocortisoneTestosterone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsAndrostenolsAndrostenesAndrostanesTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Peter Y Liu, MD PhD

    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 6, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2017

Study Completion

October 1, 2023

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Statistical Analysis Plan Access

Locations

US(1)