Sleep Extension or Regularity to Reduce Diabetes Risk

NCT ID: NCT06128265

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2024-12-31

Brief Summary

The goal of this study is to identify an intervention that improves sleep health and consequently metabolic health by examining whether sleep extension or enforced regularity in short sleepers will have beneficial effects on diabetes and obesity risk.

Detailed Description

Numerous studies of restricted sleep have revealed insufficient sleep as a novel risk factor for metabolic disease. Specifically, it has been reported that insufficient sleep resulted in impairments in appetite regulation, energy intake, glucose tolerance, and insulin sensitivity. Further, recent studies have begun to reveal that the regularity of sleep timing may also impact metabolic health, in that increased sleep variability was associated with greater cardio-metabolic risk. Alternatively, only a few studies have explored whether sleep extension could be beneficial to metabolic outcomes, and no studies have focused on improved regularity or racial disparities. These studies have revealed improvements in glucose metabolism and caloric intake in predominantly non-Hispanic White individuals. Therefore, in this pilot study, we seek to examine whether sleep extension or enforced regularity can improve diabetes and obesity risk in a population known to be differentially impacted by sleep deficiency and metabolic disease, short sleeping African American and Black adults.

The investigator proposes to first assess sleep duration, food intake, ratings of hunger/appetite and reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance in short sleeping overweight African American and Black adults during a baseline/habitual sleep assessment. Participants will then be randomized to one of two different 14-day sleep interventions: sleep extension or sleep regularity. Following the intervention, assessments of food intake, ratings of hunger/appetite and reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance will be repeated. The goal of this pilot project is to demonstrate feasibility of our study design, particularly effectively impacting sleep in the home. The aims of this pilot study are to demonstrate:

1. that participants can extend sleep by ~2 hours or adhere to sleep regularly within a 30min window at home for two weeks,

2. changes in glucose metabolism following the interventions and

3. changes in subjective hunger/appetite ratings and food intake

This experimental approach is expected to reveal novel and important interventions that can have a beneficial impact on the risk of diabetes and obesity in an understudied population that suffers from increased risk, short sleeping overweight African American and Black adults.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Extension

Participants that are in the sleep extension group will have their time in bed extended by 2 hours. This can include going to bed earlier and/or waking up later.

Group Type: EXPERIMENTAL

Sleep Extension

Intervention Type: BEHAVIORAL

Extending time in bed by 2 hours (going to bed earlier and/or waking up later)

Sleep Regularity

Participants in the sleep regularity group will have consistent bedtimes (within 30min).

Group Type: EXPERIMENTAL

Sleep Regularity

Intervention Type: BEHAVIORAL

Consistent bedtimes (within 30min)

Interventions

Sleep Extension

Extending time in bed by 2 hours (going to bed earlier and/or waking up later)

Intervention Type: BEHAVIORAL

Sleep Regularity

Consistent bedtimes (within 30min)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• African American or Black men and women
• Age 21-50 years old
• Overweight (BMI greater than or equal 25 kg/m2 and less than 35 kg/m2)
• Self-reported short sleep (less than 7hrs/night, sleep between 22:00-08:00, and who indicate they could sleep more if they had the opportunity)
• No previously diagnosed sleep disorders (including obstructive sleep apnea (OSA))
• No existing diagnosis of diabetes
• No history of endocrine dysfunction
• No history of psychiatric, cardiovascular, or eating disorders, not having a gastro-intestinal disease that requires dietary adjustment,
• Currently taking no medications (excluding statins and birth control)

Exclusion Criteria

• Drug and nicotine use
• Habitual alcohol use of more than 2 drinks per day
• Caffeine intake of more than 500 mg per day
• Subjects who participated in medically managed weight loss program within the past year
• Subjects who have undergone bariatric surgery,
• Subjects who have dietary restrictions,
• Subjects who worked night shifts, or crossed any time zones in the month prior to the study.
• Sleep-disordered breathing (apnea-hypopnea index>15 events/hour) from an overnight at home sleep test (NOX)
• Peri- and post-menopausal women will not be included.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Hanlon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB23-1060

Identifier Type: -

Identifier Source: org_study_id