Sleep Extension or Regularity to Reduce Diabetes Risk

NCT06128265 | Completed

• 1 other identifier: IRB23-1060
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (7)

• Sleep outcome measures- Sleep time

  A decrease in time to sleep onset from baseline to day 24 measured in time of day by Wrist Actigraphy Monitoring.

  Baseline to Day 24

• Sleep Outcome- Wake time

  Change in wake time from baseline to day 24 measured in time of day by Wrist Actigraphy Monitoring.

  Baseline to Day 24

• Sleep outcome- Sleep duration

  Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.

  Baseline to Day 24

• Sleep Outcome- Regularity of sleep

  Change in regularity of sleep from baseline to day 24 measured by Wrist Actigraphy Monitoring. The value is from standard deviation of time of middle of the sleep period.

  Baseline to Day 24

• Sleep Outcome- Sleep Efficiency

  Change in sleep efficiency from baseline to day 24 measure by a percentage of total sleep time/time in bed from Wrist Actigraphy Monitoring.

  Baseline to Day 24

• Change in glucose homeostasis after 24 days

  The Matsuda Index of whole body insulin sensitivity, the homeostasis model assessment (HOMA) measures beta cell function and insulin resistance will be measured by Oral glucose tolerance test (OGTT).

  Baseline to Day 24

• Change in glucose homeostasis measured by Continuous Glucose Monitor (CGM)

  Mean Absolute Glucose (MAG - mg/dl), Coefficient of Variation (CV - mg/dl), Standard Deviation (SD-mg/dl), Area Under the Curve (AUC - mg/dl), Time Spent in Range (TIR - minutes), Continuous Overall Net Glycemic Action (CONGA - (mg/dl) per minutes) will be measured by Continuous Glucose Monitor (CGM).

  Baseline to Day 24

Secondary Outcomes (5)

• Changes from baseline through day 24 of novel Patient Reported Outcome instrument

  Baseline to Day 24

• Glucose Homeostasis-First phase insulin response

  Baseline to Day 24

• Glucose Homeostasis-Oral disposition index (DIo)

  Baseline to Day 24

• Glucose Homeostasis- insulinogenic index

  Baseline to Day 24

• Weight in kg, measured from screening through study completion.

  Screening to Day 24

Study Arms (2)

Sleep Extension

EXPERIMENTAL

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.

Behavioral: Sleep Extension

Sleep Regularity

EXPERIMENTAL

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

Behavioral: Sleep Regularity

Interventions

Sleep Extension BEHAVIORAL

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

Sleep Extension

Sleep Regularity BEHAVIORAL

Consistent bedtimes (within 30min)

Sleep Regularity

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Hanlon, Ph.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized and unblinded

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: January 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)