Effects of Sleep Duration and Architecture on Insulin Sensitivity

Study Overview
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Brief Summary
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This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in comparison to normal sleep, will: Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the hyperinsulinemic-euglycemic clamp and oral glucose tolerance test. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of endogenous glucose production, gluconeogenesis and glycogenolysis.

Detailed Description
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Over the past 50 years, the incidence of diabetes has increased dramatically, while sleep duration in the US has decreased significantly. Epidemiological studies and small clinical trials suggest that these trends are causally related. In this study, our goal is to determine the mechanisms by which decreased sleep duration directly affects insulin sensitivity. The investigators will perform a clinical study in 20 healthy volunteers to determine whether 5 nights of sleep restriction decreases insulin sensitivity in the peripheral tissues (ie, skeletal muscle) or liver. Peripheral insulin sensitivity will be measured by the hyperinsulinemic-euglycemic clamp, and hepatic insulin sensitivity will be quantified by measurement of hepatic glucose production, gluconeogenesis and glycogenolysis (using stable isotope tracer methods). Subjects will be randomized to an initial period of normal sleep or sleep restriction and will be admitted to the Clinical Research Center (CRC) for 9 days to undergo comprehensive metabolic studies and sleep assessments under the assigned sleep condition. After a 1-month washout period, subjects will be re-admitted to the CRC to undergo these same assessments under the opposite sleep condition.

Official Title
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Effects of Sleep Duration and Architecture on Insulin Sensitivity

Conditions
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Insulin Resistance

Intervention / Treatment
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* Behavioral: Sleep restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 years Regular work hours (ie, no night-time or shift work within the past 6 months) Pittsburgh Sleep Quality Index (PSQI) Score <5 Average nightly sleep duration 6-9 hours (per screening actigraphy) Exclusion Criteria: Current or prior diabetes, gestational diabetes, impaired glucose tolerance or impaired fasting glucose Type 2 diabetes in biological parents BMI >=25 Pregnancy Chronic medical condition, including: psychiatric disorders, heart disease, pulmonary disease, infectious diseases, rheumatological and neurological disorders Use of prescribed medications on a regular basis. History of disorder involving hypothalamic, pituitary or adrenal glands History of or current sleep disorders (insomnia, restless leg syndrome, sleep disordered breathing, narcolepsy, etc) Anemia Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleep restriction<br>The investigators will compare the effects of sleep restriction vs. normal sleep in healthy volunteers, using a randomized crossover study design. Each subject will undergo a period of normal sleep and a period of sleep restriction, separated by a 1-month washout period. Subjects will be randomized to receive either sleep restriction first (later followed by normal sleep) or normal sleep first (later followed by sleep restriction). | Behavioral: Sleep restriction<br>* Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes