Sleep DeprivationNCT06809023
Evaluation of Sex Differences in Glucose Metabolism in Response to Sleep Curtailment
A study testing Sleep restriction in people with Sleep Deprivation and Sex Differences, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this study is to learn whether insufficient sleep affects glucose metabolism differently in healthy men and women. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sex Differences, Glucose Tolerance
- What is being tested?
- Sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Hearing impairment, visual impairment
- History of eye trauma or surgery
- Drug or alcohol dependency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this study is to learn whether insufficient sleep affects glucose metabolism differently in healthy men and women.
Read the 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.
- Conditions
- Sleep Deprivation, Sex Differences, Glucose Tolerance
- Being tested
- Sleep restriction
- Keywords
- glucose metabolism, sleep deprivation, sex differences, GLP-1
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
Participants will be asked to sleep 4h/night
| Study group | Role | What they receive |
|---|---|---|
| Sleep restriction | Experimental | Participants undergo sleep restriction to 4 hours/night Receives: Behavioral: Sleep restriction |
| Control condition | No intervention | Participants undergo the control condition (no sleep restriction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between men and women in postprandial glucose response after Sleep Restriction
Test the hypothesis that three nights of sleep curtailment increases postprandial glucose levels to a greater extent in women compared to men. Postprandial glucose will be assessed in response to a standard meal after Control and Sleep Restriction. The change in postprandial glucose from Control to Sleep Restriction will be compared between men and women.
Measured: Study Day 4 (Arm 1) vs. Study Day 4 (Arm 2)
Difference between men and women in postprandial GLP-1 response after Sleep Restriction
Test the hypothesis that three nights of sleep curtailment decreases postprandial GLP-1 levels to a greater extent in women compared to men. Postprandial GLP-1 levels will be assessed in response to a standard meal after Control and Sleep Restriction. The change in postprandial GLP-1 from Control to Sleep Restriction will be compared between men and women.
Measured: Study Day 4 (Arm 1) vs. Study Day 4 (Arm 2)
Secondary outcomes (2)
Difference between men and women in fasting glucose after Sleep Restriction
Test the hypothesis that three nights of sleep curtailment increases fasting glucose levels to a greater extent in women compared to men. Fasting glucose will be assessed overnight during the habitual sleep period after Control and Sleep Restriction. The change in fasting glucose from Control to Sleep Restriction will be compared between men and women.
Measured: Study Day 5 (Arm 1) vs. Study Day 5 (Arm 2)
Difference between men and women in fasting GLP-1 after Sleep Restriction
Test the hypothesis that three nights of sleep curtailment decreases fasting GLP-1 levels to a greater extent in women compared to men. Fasting GLP-1 levels will be assessed overnight during the habitual sleep period after Control and Sleep Restriction. The change in fasting GLP-1 from Control to Sleep Restriction will be compared between men and women.
Measured: Study Day 5 (Arm 1) vs. Study Day 5 (Arm 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study startApr 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a within-subjects randomized crossover design to compare the effects of sleep restriction to a control condition where participants are not sleep restricted.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles A. Czeisler, PhD, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809023
- Sponsor's protocol ID
- 2025-P-000064
- Status last verified
- Dec 2025
- First submitted
- 24 Jan 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sex Differences in Glucose Metabolism in Response to Sleep Curtailment
- ClinicalTrials.gov ID
- NCT06809023
- Acronym / sponsor ID
- 2025-P-000064
- Conditions
- Sleep Deprivation, Sex Differences, Glucose Tolerance
- Keywords
- glucose metabolism, sleep deprivation, sex differences, GLP-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study uses a within-subjects randomized crossover design to compare the effects of sleep restriction to a control condition where participants are not sleep restricted.
| Arm | Type | Receives |
|---|---|---|
| Sleep restriction | Experimental | Behavioral: Sleep restrictionParticipants undergo sleep restriction to 4 hours/night |
| Control condition | No intervention | –Participants undergo the control condition (no sleep restriction) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep restrictionParticipants will be asked to sleep 4h/night | Behavioural | Sleep restriction |
Primary outcome
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)
Test the hypothesis that three nights of sleep curtailment increases postprandial glucose levels to a greater extent in women compared to men. Postprandial glucose will be assessed in response to a standard meal after Control and Sleep Restriction. The change in postprandial glucose from Control to Sleep Restriction will be compared between men and women.
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)
Test the hypothesis that three nights of sleep curtailment decreases postprandial GLP-1 levels to a greater extent in women compared to men. Postprandial GLP-1 levels will be assessed in response to a standard meal after Control and Sleep Restriction. The change in postprandial GLP-1 from Control to Sleep Restriction will be compared between men and women.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction in people with Sleep Deprivation and Sex Differences, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.