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Completed

NCT Number: NCT00989976

Individual Differences in Diabetes Risk: Role of Sleep Disturbances

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).

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

normal sleep times

Behavioral

8.5 h bedtimes

bedtime restriction

Behavioral

4.5 h restricted bedtimes

Primary outcomes

  1. diabetes risk as assessed by disposition index

    Time frame: Dec. 2011

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 6, 2009
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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