Sleep Extension or Regularity to Reduce Diabetes Risk in African American Adults

Overweight or Obesity Clinical Trial

Official title:

Sleep Extension or Regularity to Reduce Diabetes Risk in African American Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128265
• Other study ID #: IRB23-1060
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Erin Hanlon, Ph.D.
• Phone: (773) 702-3275
• Email: ehanlon[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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 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 adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• African American men and women
• Age 21-50 years old
• Overweight (BMI greater than or equal 25 kg/m2 and less than 30 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.

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Behavioral:
• Sleep Extension
Extending time in bed by 2 hours (going to bed earlier and/or waking up later)
• Sleep Regularity
Consistent bedtimes (within 30min)

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Sleep outcome- Sleep duration	Change in Sleep duration from baseline to day 24 measured in minutes by Wrist Actigraphy Monitoring.	Baseline to Day 24
Primary	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
Primary	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
Primary	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
Primary	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	Changes from baseline through day 24 of novel Patient Reported Outcome instrument	Detection of within-patient changes in sleep effects (sleepiness), appetite, mood, reported in a novel Patient-Reported Outcome instrument between baseline and Day 24.	Baseline to Day 24
Secondary	Glucose Homeostasis-First phase insulin response	Changes in first phase insulin response (ARIg=mu.i^-1.min) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).	Baseline to Day 24
Secondary	Glucose Homeostasis-Oral disposition index (DIo)	Changes in oral disposition index (DIo) from baseline to Day 24 measured in (SI x ARIg = [(mu/l)^-1.min^-1] * [mu.l^-1.min]) by oral glucose tolerance test (OGTT).	Baseline to Day 24
Secondary	Glucose Homeostasis- insulinogenic index	Changes in insulinogenic index (change in plasma insulin/change in plasma glucose from 0-30 minutes = (pmol/L)/(mg/dL)) from baseline to Day 24 measured by oral glucose tolerance test (OGTT).	Baseline to Day 24
Secondary	Weight in kg, measured from screening through study completion.	The change in weight values will be measured by in laboratory anthropometrics measurements.	Screening to Day 24