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Home Sleep and Circadian Phase: Mediators of Diabetes Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01786564
Recruitment Status : Active, not recruiting
First Posted : February 8, 2013
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Kristen Knutson, 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.

Condition or disease
Sleep Deprivation Diabetes Circadian Dysregulation

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Home Sleep and Circadian Phase: Mediators of Diabetes Risk
Actual Study Start Date : December 6, 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020



Primary Outcome Measures :
  1. Oral Disposition Index [ Time Frame: baseline ]
    The oral disposition index from a frequently sampled 5-hour oral glucose tolerance test will be the primary outcome of interest.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will recruit a total of 100 African Americans (AA) and 100 non-Hispanic whites (WH) with equal numbers of men and women in each group completing the entire study. Ages will be 21-50 years and body mass indices (BMI) will be <40 kg/m2.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786564


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Kristen Knuston, PhD Northwestern University

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Responsible Party: Kristen Knutson, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01786564     History of Changes
Other Study ID Numbers: STU00204605
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristen Knutson, Northwestern University:
diabetes
sleep
Additional relevant MeSH terms:
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Sleep Deprivation
Chronobiology Disorders
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders