Effects of Sleep Duration and Architecture on Insulin Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of California, San Francisco.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Madhu Rao, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01396941
First received: July 15, 2011
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention
Insulin Resistance
Behavioral: Sleep restriction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Sleep Duration and Architecture on Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.


Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: sleep restriction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396941

Locations
United States, California
UCSF San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Madhu N. Rao, MD    415-206-6381    madhu.rao@ucsf.edu   
Principal Investigator: Madhu N. Rao, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Madhu N. Rao, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Madhu Rao, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01396941     History of Changes
Other Study ID Numbers: K23HL096832, K23HL096832
Study First Received: July 15, 2011
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Diabetes

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014