Clinical Trials Directory

Trials / Completed

CompletedNCT06128265

Sleep Extension or Regularity to Reduce Diabetes Risk

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
21 Years – 50 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALSleep ExtensionExtending time in bed by 2 hours (going to bed earlier and/or waking up later)
BEHAVIORALSleep RegularityConsistent bedtimes (within 30min)

Timeline

Start date
2024-01-03
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2023-11-13
Last updated
2025-09-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06128265. Inclusion in this directory is not an endorsement.