Individual Differences in Diabetes Risk: Role of Slow WaveSleep

September 4, 2013 updated by: University of Chicago

Ancillary Studies to Major Ongoing NIDDK Clinical Research Studies

This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 20 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

normal healthy men and women

Description

Inclusion Criteria:

  • healthy volunteers age 18-20 with a BMI < 27kg/m2 in women and < 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG
  • only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks)
  • habitual bedtimes between 7.0-8.5 hours/night
  • do not take medications will be recruited

Exclusion Criteria:

  • women taking hormonal contraceptive therapy and pregnant women will be excluded
  • individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded
  • other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
normal healthy men and women
Behavioral: baseline study
normal bedtimes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of Slow Wave Activity determines insulin sensitivity.
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16026A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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