Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Not Applicable

Completed

• Conditions: Sleep; Diabetes
• Interventions: Behavioral: normal sleep times; Behavioral: bedtime restriction

• Registration Number: NCT00989976
• Lead Sponsor: University of Chicago

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
8.5 h sleep	normal sleep times	Subjects will have normal sleep times
restricted bedtimes	bedtime restriction	4.5 h bedtimes

Primary Outcome Measures

Name	Time	Method
diabetes risk as assessed by disposition index	Dec. 2011

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States