Individual Differences in Diabetes Risk: Role of Sleep Disturbances

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989976

Enrollment

Registered

2009-10-06

Start date

2009-02-28

Completion date

2014-08-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Sleep

Keywords

Sleep, Diabetes Risk

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).

Interventions

BEHAVIORALnormal sleep times

8.5 h bedtimes

BEHAVIORALbedtime restriction

4.5 h restricted bedtimes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 29 Years

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.

Design outcomes

Primary

Measure	Time frame
diabetes risk as assessed by disposition index	Dec. 2011

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026