Individual Differences in Diabetes Risk: Role of Sleep Disturbances

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00989976
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 65.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sleep; Diabetes	Behavioral: normal sleep times; Behavioral: bedtime restriction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Individual Differences in Diabetes Risk: Role of Sleep Disturbances
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 8.5 h sleep Subjects will have normal sleep times	Behavioral: normal sleep times; 8.5 h bedtimes
Other: restricted bedtimes 4.5 h bedtimes	Behavioral: bedtime restriction; 4.5 h restricted bedtimes

Outcome Measures

Primary Outcome Measures

1. diabetes risk as assessed by disposition index [Dec. 2011]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00989976
• Other Study ID Numbers: #16028A; DOD PR064727
• First Posted: Oct 6, 2009
• Last Update Posted: Dec 8, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by University of Chicago: Sleep; Diabetes Risk
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Diabetes Mellitus

Study Results

No Results Posted as of Dec 8, 2014