Individual Differences in Diabetes Risk: Role of Slow WaveSleep

Diabetes Clinical Trial

Official title:

Ancillary Studies to Major Ongoing NIDDK Clinical Research Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989378
• Other study ID #: 16026A
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: September 4, 2013
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 20 Years

Eligibility

Inclusion Criteria:

• healthy volunteers age 18-20 with a BMI < 27kg/m2 in women and < 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG

• only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks)

• habitual bedtimes between 7.0-8.5 hours/night

• do not take medications will be recruited

Exclusion Criteria:

• women taking hormonal contraceptive therapy and pregnant women will be excluded

• individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded

• other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes
• Sleep

Intervention

Behavioral:
• baseline study
normal bedtimes

Locations

Country	Name	City	State
United States	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	Amount of Slow Wave Activity determines insulin sensitivity.		2 days	No