Improved Sleep for Obesity and Diabetes Risk Reduction

Overseen By Silvana Pannain, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Drugs, Nicotine, Alcohol, Caffeine

Disqualifiers: Sleep disorders, Diabetes, Endocrine dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if longer and more regular sleep can reduce risks related to diabetes and obesity. Participants will either receive two additional hours of sleep (Sleep Extension) or maintain a consistent bedtime each night (Sleep Regularity). The trial seeks African American or Black individuals who are overweight, sleep less than 7 hours a night, and do not have existing sleep disorders or diabetes. As an unphased trial, this study offers a unique opportunity to contribute to important research on sleep and health.

Will I have to stop taking my current medications?

Participants must not be taking any medications, except for statins and birth control, to join the trial.

What prior data suggests that these sleep interventions are safe?

Research has shown that getting more sleep and maintaining a regular sleep schedule can safely improve health. Studies on increased sleep suggest it might help people eat less and lose weight, particularly if they are overweight, thereby reducing the risk of obesity.

A regular sleep schedule is associated with better heart health and metabolism. Irregular sleep patterns can raise the risk of type 2 diabetes and obesity, so adhering to a regular sleep routine might help mitigate these risks. These findings indicate that regular sleep is a safe and beneficial goal.

Overall, both getting more sleep and maintaining a regular sleep schedule appear to be safe methods with potential health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these sleep-based approaches because they offer a non-pharmaceutical option for reducing obesity and diabetes risks. Unlike traditional methods that often involve medications or complex lifestyle changes, sleep extension simply increases the time spent in bed, potentially improving metabolic health by allowing more restorative sleep. Meanwhile, sleep regularity focuses on consistent sleep schedules, which can stabilize circadian rhythms and improve overall sleep quality. These methods are unique because they harness the body's natural processes, providing a holistic and accessible way to tackle these health issues.

What evidence suggests that this trial's treatments could be effective for improving sleep and reducing obesity and diabetes risk?

This trial will compare two sleep interventions: Sleep Extension and Sleep Regularity. Research has shown that getting more sleep, as tested in the Sleep Extension arm, can help people eat less and lose weight, benefiting those who are overweight. One study found that sleeping longer led to these positive changes in everyday life. Other research suggests that more sleep can lower the risk of obesity and improve heart and overall health.

The Sleep Regularity arm will test the effects of maintaining a consistent sleep schedule. Studies indicate that a regular sleep schedule can reduce the risk of developing type 2 diabetes. In contrast, irregular sleep can increase the risk of diabetes and other health issues. Keeping a consistent sleep routine is linked to better overall health and a lower risk of diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

Erin Hanlon, Ph.D.

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for African American adults aged 21-50 who are overweight with a BMI of 25 to 30 and usually sleep less than 7 hours at night. Participants should have the potential to sleep more if they had the time.

Inclusion Criteria

I am between 22 and 50 years old.

I usually sleep less than 7 hours a night.

I am African American.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline/Habitual Sleep Assessment

Assessment of sleep duration, food intake, hunger/appetite ratings, reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance

1 week

1 visit (in-person)

Intervention

Participants are randomized to either sleep extension or sleep regularity intervention for 14 days

2 weeks

Daily monitoring (remote)

Post-Intervention Assessment

Reassessment of food intake, hunger/appetite ratings, reward-related eating, daily interstitial glucose, resting metabolic rate, insulin sensitivity, and glucose tolerance

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in sleep and metabolic health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Extension
• Sleep Regularity

Trial Overview The study is testing two approaches to improve sleep health: one group will try sleeping longer (sleep extension), while another will focus on keeping a consistent sleep schedule (sleep regularity). The aim is to see if these methods can lower diabetes and obesity risk.

How Is the Trial Designed?

Group I: Sleep Regularity Experimental Treatment 1 Intervention

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

Group II: Sleep Extension Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140617/

Sleep Extension: A potential target for obesity treatment Sleep extension has the potential to attenuate obesity risk and cardiometabolic dysfunction. There is tremendous opportunity for future research.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06128265

Sleep Extension or Regularity to Reduce Diabetes Risk The goal of this study is to identify an intervention that improves sleep health and consequently metabolic health by examining whether sleep extension or ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2788694

Effect of Sleep Extension on Objectively Assessed Energy ... This trial found that sleep extension reduced energy intake and resulted in a negative energy balance in real-life settings among adults with overweight.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4112413/

The Effects of Extended Bedtimes on Sleep Duration and ... We demonstrated that a 2-week home-based behavioral intervention to extend bedtimes results in increased sleep duration in overweight young adults who ...

5. joe.bioscientifica.com joe.bioscientifica.com/view/journals/joe/252/2/JOE-21-0155.xml

The links between sleep duration, obesity and type 2 diabetes ... In addition, small studies suggested that short sleep duration was associated with less weight loss following lifestyle interventions or bariatric surgery. In ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8679843/

The links between sleep duration, obesity and type 2 ... Based to cohort-included meta-analytic data, short sleep duration has been consistently associated with increased risk of obesity (whether defined based on BMI ...

7. diabetesjournals.org diabetesjournals.org/care/article/47/3/331/154247/Waking-Up-to-the-Importance-of-Sleep-in-Type-2

Waking Up to the Importance of Sleep in Type 2 Diabetes ... These findings corroborate previous meta-analysis, where poor sleep quality was associated with a 40–84% increased risk of developing type 2 ...