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Completed

NCT Number: NCT01396941

Effects of Sleep Duration and Architecture on Insulin Sensitivity

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Restriction

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

Primary outcomes

  1. Insulin sensitivity

    Time frame: 1 month

    Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 19, 2011
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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