Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Study Overview
=================
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).

Official Title
-----------------
Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Conditions
-----------------
Sleep, Diabetes

Intervention / Treatment
-----------------
* Behavioral: normal sleep times
* Behavioral: bedtime restriction


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 8.5 h sleep<br>Subjects will have normal sleep times | Behavioral: normal sleep times<br>* 8.5 h bedtimes<br>|
| Other: restricted bedtimes<br>4.5 h bedtimes | Behavioral: bedtime restriction<br>* 4.5 h restricted bedtimes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes risk as assessed by disposition index |  | Dec. 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Diabetes Risk