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Effects of Sleep Duration and Architecture on Insulin Sensitivity

Effects of Sleep Duration and Architecture on Insulin Sensitivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01396941
Enrollment
10
Registered
2011-07-19
Start date
2011-05-31
Completion date
2014-12-31
Last updated
2021-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

Diabetes

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.

Interventions

BEHAVIORALSleep 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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin sensitivity1 monthPeripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026