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Does Circadian Misalignment Have Sex-Specific Effects on Metabolism?

Role of Biological Sex in Metabolic Responses to Night Work

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07441265
Enrollment
36
Registered
2026-02-27
Start date
2026-10-01
Completion date
2030-09-30
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Misalignment, Sex Differences

Keywords

circadian rhythm, sex differences, night work, glucose control, appetite regulation

Brief summary

This study will test whether biological sex influences how the body responds to circadian misalignment-a mismatch between the internal body clock and the timing of sleep and eating (as can occur with shift work or jet lag). Researchers will examine how circadian misalignment affects appetite regulation (hunger/fullness) and glucose metabolism (blood sugar control), and whether these effects differ between females and males. Findings may help inform more personalized shift work schedules and targeted strategies to reduce metabolic health risks and sex-related differences in clinical care.

Detailed description

This study will examine whether biological sex affects how the body responds to circadian misalignment-a mismatch between a person's internal body clock and their sleep/wake and eating schedule (similar to what can happen with night shift work, jet lag, or frequently changing sleep schedules). Researchers will measure how circadian misalignment influences appetite regulation (such as hunger and fullness) and glucose metabolism (how the body controls blood sugar), and whether these effects differ between females and males. By identifying sex-specific responses to circadian misalignment, this research may help guide the development of safer, more personalized shift work schedules and targeted strategies to reduce metabolic health risks, with the goal of improving clinical care and reducing sex-related differences in metabolic disease risk.

Interventions

BEHAVIORALDay shift

Research participants will be assigned to day shift condition in which sleep-wake and meal schedules are aligned with the internal circadian system

BEHAVIORALNight shift

Research participants will be assigned to simulated night shift condition in which sleep-wake and meal schedules are misaligned with the internal circadian system

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-40 years of age * Body Mass Index 18.5-24.9 kg/m2 * Non-smokers, no current tobacco or e-cigarette use * Healthy with no acute or chronic medical and psychiatric disorders * Sex assigned at birth consistent with reproductive anatomy at enrollment (per protocol definition)

Exclusion criteria

* History of drug or alcohol dependency * History of psychiatric illness or disorder * Pregnant * No prior gender-affirming hormone therapy and no gonadectomy

Design outcomes

Primary

MeasureTime frameDescription
Difference in circulating leptin levels between Night Shift and Day Shift24 hoursDifferences of 24-h circulating leptin levels on the test days in the two experimental conditions
Differences in Disposition index (DI) derived from identical test breakfast between Night Shift and Day Shift3 hoursDisposition index (DI) derived from oral minimal model based on postprandial glucose, insulin, and c-peptide responses to identical test breakfast on the test days between protocols
Differences in self-rated cravings for hyperpalatable food during the wake period between Night Shift and Day Shift.16 hoursDifferences in self-rated cravings for hyperpalatable food during the wake period on the test days between protocols.

Countries

United States

Contacts

CONTACTJingyi Qian, PhD
jqian5@mgb.org617-525-7423
PRINCIPAL_INVESTIGATORJingyi Qian, PhD

Brigham and Women's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026