Metabolic Effects of Sleep Extension in People With Obesity

Study Overview
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Brief Summary
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This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed to 8 hours (sleep extension) while the other half will be be instructed to maintain their current sleep habits.

Detailed Description
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Restricting sleep is known to be detrimental to glucose metabolism in healthy adults. Obesity is a condition associated with both lower sleep duration and poor glucose tolerance. Therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. The investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep extension intervention in both the control and sleep extension groups.

Official Title
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Metabolic Effects of Sleep Extension in People With Obesity

Conditions
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Insulin Resistance, Obesity

Intervention / Treatment
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* Behavioral: Sleep extension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleep <6h/night Body mass index 30-45 kg/m2 Altered glucose metabolism (any of the following) Fasting glucose ≥100 mg/dL or, 2-h plasma glucose ≥140 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c ≥5.7% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.5 Exclusion Criteria: Sleep disorders Excessive caffeine or alcohol consumption Significant organ dysfunction/disease (e.g. diabetes, kidney disease) Prior bariatric surgery Pregnancy Tobacco or illicit drug use Perform regular moderate or intense exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Normal sleep habits < 6h | |
| Experimental: Sleep Extension<br>Extend time-in-bed to 8 hours | Behavioral: Sleep extension<br>* Extend time-in-bed to 8 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity | Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp | Change from baseline testing after 4-6 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour metabolite concentrations | Plasma metabolite concentrations will be evaluated over a 24 hour period | Change from baseline testing after 4-6 weeks of intervention | 
| 24 hour hormone concentrations | Plasma hormone concentrations will be evaluated over a 24 hour period | Change from baseline testing after 4-6 weeks of intervention | 
| 24 hour cytokine concentrations | Plasma cytokine concentrations will be evaluated over a 24 hour period | Change from baseline testing after 4-6 weeks of intervention | 
| regulation of circadian rhythm | Expression of peripheral clock genes | Change from baseline testing after 4-6 weeks of intervention | 
| Body composition | Body composition will be assessed using dual-energy x-ray absorptiometry (DXA) and magnetic resonance scanning | Change from baseline testing after 4-6 weeks of intervention | 
| Sleep study | Sleep staging will be assessed during an inpatient sleep study | Change from baseline testing after 4-6 weeks of intervention |