Menu
Not yet recruiting NCT06809023

Evaluation of Sex Differences in Glucose Metabolism in Response to Sleep Curtailment

No phase Interventional Sleep Deprivation Sex Differences Glucose Tolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep restriction.
Who it may be relevant to
Registry conditions: Sleep Deprivation, Sex Differences, Glucose Tolerance. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this study is to learn whether insufficient sleep affects glucose metabolism differently in healthy men and women.

Detailed description

Two-thirds of Americans report regularly obtaining an insufficient amount of sleep. Chronic sleep deficiency is associated with negative health consequences such as obesity, cardiovascular disease, diabetes, and metabolic syndrome. Laboratory studies have shown that sleep restriction reduces glucose tolerance in otherwise healthy adults, and it is now well established that sleep restriction decreases insulin sensitivity. However, there is a significant gap in the literature regarding how sex differences may drive disparate metabolic outcomes in men and women in response to sleep loss.

Epidemiological studies strongly suggest that women and men may respond differently to the physiological challenges associated with sleep restriction and circadian disruption. Trouble sleeping is more prevalent in women compared to men, and sleep disturbances appear to be associated with higher risk of obesity, hypertension, and elevated HbA1c in women compared to men. Although multiple causative mechanisms have been explored, most laboratory studies investigating the mechanisms by which sleep disturbances impair metabolism have been conducted solely in men or have not been powered for sex differences.

One potential mechanism underlying sex differences in glucose regulation after sleep loss is the glucagon-like peptide-1 (GLP-1) pathway. GLP-1 reduces blood glucose by stimulating insulin secretion and inhibiting glucagon secretion in response to food intake and is the target of promising new treatments for insulin resistance and obesity such as Ozempic and Wegovy. Interestingly, women exhibit a greater response to treatment with these GLP-1 receptor agonist drugs; additionally, one laboratory study found decreased GLP-1 levels in women but not in men after 4 days of sleep curtailment.

This study will use a randomized crossover design in young men and premenopausal women to test the hypotheses that sleep loss impairs glucose tolerance more in women than in men, and that this difference is partially mediated by sex-dependent responses in GLP-1 after sleep curtailment.

Currently, there are no sex-specific recommendations for management of diabetes or sleep loss, despite evidence that women may bear a greater disease burden than men. Understanding sex differences in glucose metabolism in response to sleep curtailment is critical for making more effective and individualized treatment recommendations to mitigate the adverse metabolic effects of sleep restriction in women and men.

Interventions

  • Behavioral Sleep restriction
    Participants will be asked to sleep 4h/night

Primary outcome measures

  • Difference between men and women in postprandial glucose response after Sleep Restriction [Time frame: Study Day 4 (Arm 1) vs. Study Day 4 (Arm 2)]
  • Difference between men and women in postprandial GLP-1 response after Sleep Restriction [Time frame: Study Day 4 (Arm 1) vs. Study Day 4 (Arm 2)]
Secondary outcome measures (2)
  • Difference between men and women in fasting glucose after Sleep Restriction [Time frame: Study Day 5 (Arm 1) vs. Study Day 5 (Arm 2)]
  • Difference between men and women in fasting GLP-1 after Sleep Restriction [Time frame: Study Day 5 (Arm 1) vs. Study Day 5 (Arm 2)]

Eligibility criteria

Inclusion criteria

  • Healthy adults with conventional sleep-wake timing
  • Non-smokers
  • Completion of medical, psychological, and sleep screening tests
  • Able to spend 5 consecutive days/nights in the laboratory on two separate occasions (total of 10 days/nights in the laboratory)
  • Women must have a recent history of regular menstrual cycles

Exclusion criteria

  • History of neurological or psychiatric disorder
  • History of sleep disorder or regular use of sleep-promoting medication
  • Current prescription, herbal, or over-the-counter medication use including hormonal birth control
  • Traveling across 2 or more time zones within past 3 months
  • Donating blood within past 8 weeks
  • Worked night or rotating shift work within past year
  • Hearing impairment, visual impairment
  • History of eye trauma or surgery
  • Drug or alcohol dependency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT06809023 · 2025-P-000064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗