Individual Differences in Diabetes Risk: Role of Sleep Disturbances

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00989976
First received: October 1, 2009
Last updated: December 5, 2014
Last verified: December 2014
  Purpose

The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).


Condition Intervention
Sleep
Diabetes
Behavioral: normal sleep times
Behavioral: bedtime restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • diabetes risk as assessed by disposition index [ Time Frame: Dec. 2011 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
8.5 h sleep
Subjects will have normal sleep times
Behavioral: normal sleep times
8.5 h bedtimes
restricted bedtimes
4.5 h bedtimes
Behavioral: bedtime restriction
4.5 h restricted bedtimes

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the gender distribution in each group matching the gender distribution of active duty Army personnel (85% men; 15% women) based on the following inclusion criteria:

    • age 18 to 29 years,
    • normal weight or modestly overweight (BMI ≤ 27 kg/m2 for women, BMI ≤ 28 kg/m2 for men),
    • normal findings on clinical examination, normal routine laboratory tests results, normal EKG, no history of psychiatric, endocrine, cardiac or sleep disorders.
  • Only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited.
  • An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index > 5/hour) and periodic limb movement disorder (PLM arousal index >1/hour).
  • Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase.

Exclusion Criteria:

  • Tobacco use.
  • Habitual alcohol use of more than 2 1 drink per day.
  • Excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body.

We estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high SWA.

  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: NCT00989976

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00989976     History of Changes
Other Study ID Numbers: #16028A, DOD PR064727
Study First Received: October 1, 2009
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Sleep
Diabetes Risk

Additional relevant MeSH terms:
Dyssomnias
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2015