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Home Sleep and Circadian Phase: Mediators of Diabetes Risk

NCT ID: NCT01786564

Last Updated: 2020-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-06

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Sleep Deprivation Diabetes Circadian Dysregulation

Keywords

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diabetes sleep

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Kristen Knutson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen Knuston, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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STU00204605

Identifier Type: -

Identifier Source: org_study_id