Effects of Sleep Duration and Architecture on Insulin Sensitivity

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01396941

Collaborator

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

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Behavioral: Sleep restriction	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Effects of Sleep Duration and Architecture on Insulin Sensitivity

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: 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

Arm

Intervention/Treatment

Experimental: 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).

Behavioral: 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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

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

Investigators

Principal Investigator: Madhu N. Rao, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01396941

Other Study ID Numbers:

K23HL096832
K23HL096832

First Posted:

Jul 19, 2011

Last Update Posted:

Jul 19, 2021

Last Verified:

Jul 1, 2021

Keywords provided by University of California, San Francisco

Diabetes

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Jul 19, 2021