Home Sleep and Circadian Phase: Mediators of Diabetes Risk

Completed

• Conditions: Circadian Dysregulation; Sleep Deprivation; Diabetes

• Registration Number: NCT01786564
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-08
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Results First Submitted: 2020-09-28
• Results First Submitted QC: 2020-09-28
• Results First Posted: 2020-10-22
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-24
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Ages 21-50 years
2. BMI <40 kg/m2.
3. No major illness.
4. No history of psychiatric, endocrine, cardiac or sleep disorders,
5. Premenopausal, non-pregnant women.
6. Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers).

Exclusion criteria include:

1. Persons with diabetes.
2. Persons with diagnosed sleep disorders or apnea-hypopnea index>15.
3. History of cardiovascular event or disease (excluding controlled hypertension).
4. Major psychiatric disorder or other major illness.
5. Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).
6. Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.
7. Anyone who tests positive for common drugs of abuse.
8. People with color blindness.
9. People who have had Lasik eye surgery.
10. People who work night shifts.
11. Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral Disposition Index	baseline	The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States