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

NCT06809023 | Not Yet Recruiting

• 1 other identifier: 2025-P-000064
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sex Differences; Glucose Tolerance; Sleep Deprivation

Keywords

glucose metabolism; sleep deprivation; sex differences; GLP-1

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

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

• Difference between men and women in fasting GLP-1 after Sleep Restriction

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

Study Arms (2)

Sleep restriction

EXPERIMENTAL

Participants undergo sleep restriction to 4 hours/night

Behavioral: Sleep restriction

Control condition

NO INTERVENTION

Participants undergo the control condition (no sleep restriction)

Interventions

Sleep restriction BEHAVIORAL

Participants will be asked to sleep 4h/night

Sleep restriction

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: At this time, we are recruiting cisgender men and women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The order in which participants complete the study arms is randomized
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Sleep Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)