Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Diabetes Clinical Trial

Official title:

Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989976
• Other study ID #: #16028A
• Secondary ID: DOD PR064727
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: December 5, 2014
• Start date: February 2009
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Dyssomnias
• Parasomnias
• Sleep
• Sleep Disorders

Intervention

Behavioral:
• normal sleep times
8.5 h bedtimes
• bedtime restriction
4.5 h restricted bedtimes

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diabetes risk as assessed by disposition index		Dec. 2011	No