Effects of Sleep Duration and Architecture on Insulin Sensitivity

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Behavioral: Sleep restriction

• Registration Number: NCT01396941
• Lead Sponsor: University of California, San Francisco

Brief Summary

This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in comparison to "normal sleep", will:

1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.

2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of endogenous glucose production, gluconeogenesis and glycogenolysis.

Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sleep restriction	Sleep restriction	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).

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	1 month	Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.

Trial Locations

Locations (1)

UCSF San Francisco General Hospital; 🇺🇸 San Francisco, California, United States