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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorBrigham and Women's Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sleep restriction

    Behavioral

    Participants will be asked to sleep 4h/night

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Sleep restrictionExperimental treatment 1 intervention
Group B: Control conditionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Study Day 4 (Arm 1) vs. Study Day 4 (Arm 2)
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.

Time frame
Study Day 4 (Arm 1) vs. Study Day 4 (Arm 2)

Secondary outcomes

1

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.

Time frame
Study Day 5 (Arm 1) vs. Study Day 5 (Arm 2)
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.

Time frame
Study Day 5 (Arm 1) vs. Study Day 5 (Arm 2)

Other outcomes

Sponsors and contacts

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Brigham and Women's Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

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