Effects of Sleep Duration and Architecture on Insulin Sensitivity

NCT ID: NCT01396941

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-12-31

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Sleep restriction

Intervention Type: BEHAVIORAL

Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night

Interventions

Sleep restriction

Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madhu N. Rao, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

K23HL096832

Identifier Type: NIH

Identifier Source: secondary_id

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K23HL096832

Identifier Type: NIH

Identifier Source: org_study_id

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