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Lack of sleep may trigger diabetes through hormone changes

NCT ID NCT02256865

Knowledge-focused Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at how not getting enough sleep changes hormones like cortisol and testosterone, and whether that leads to insulin resistance—a key step toward type 2 diabetes. Forty healthy men aged 22-45 took part. Researchers used drugs to mimic or block these hormone changes to understand the connection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ketoconazole, Hydrocortisone, Testosterone, and placebos
What this could lead to
If successful, this study could help explain why poor sleep increases diabetes risk, pointing toward ways to prevent it.
What could go wrong
This is a very early, small study with only 40 men. It is designed to understand mechanisms, not to test a treatment, so direct health benefits are not expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

40 people

The number who actually took part.

Start date

Oct 2014

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Insulin Resistance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insulin resistance

Contacts and locations

Locations

  • Los Angeles Biomedical Research Institute

    Torrance, California, 90509, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.