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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Oral Disposition Index | 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. | baseline |
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Inclusion Criteria:
Exclusion criteria include:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Knuston, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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Of 120 participants enrolled in the study, 56 were eligible, continued in the study and provided some data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Sample | This is a cross-sectional study so there is only one group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Sample | This is a cross-sectional study so there is only one group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oral Disposition Index | 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. | Three participants did not have adequate glucose and/or insulin values to calculate the disposition index. | Posted | Mean | Standard Deviation | None (Index) | baseline |
|
|
During study participation, approximately 2 weeks.
Definitions do not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Sample | This is a cross-sectional study so there is only one group. | 0 |
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Study sample was lower than anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Knutson | Northwestern University | 312-503-1526 | kristen.knutson@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 24, 2018 | Nov 11, 2020 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D003920 | Diabetes Mellitus |
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI), kg/m2 | Mean | Standard Deviation | kg/m2 |
|
| Habitual Sleep Duration (hours) | Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures. | Mean | Standard Deviation | minutes |
|
| Habitual sleep efficiency (% of sleep period sleeping) | Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures. | Mean | Standard Deviation | percentage |
|
| Habitual sleep start time (clock time) | Three participants did not have valid actigraphy data so habitual sleep measures could not be calculated. Thus only 53 participants have habitual sleep measures. | Mean | Standard Deviation | Hours after midnight |
|
| Duration of Stage 2 sleep (minutes) | Five participants did not have a valid PSG recording. Thus only 51 participants have sleep stage data. | Mean | Standard Deviation | Minutes |
|
| Duration of Stage 3 sleep (minutes) | Five participants did not have a valid PSG recording. Thus only 51 participants have sleep stage data. | Mean | Standard Deviation | Minutes |
|
| Duration of Rapid Eye Movement (REM) sleep (minutes) | Five participants did not have a valid PSG recording. Thus only 51 participants have sleep stage data. | Mean | Standard Deviation | Minutes |
|
| Fasting glucose levels (mg/dl) | 2 participants were missing valid fasting blood samples so only 54 have a HOMA measure. | Mean | Standard Deviation | mg/dl |
|
| Estimated Insulin Resistance (HOMA index method) | 2 participants were missing valid fasting blood samples so only 54 participants have HOMA estimated. | Mean | Standard Deviation | None (Index) |
|
| Oral Disposition Index at 30 minutes | 3 participants were missing some blood samples so the oral disposition index could not be calculated in these 3 participants. Thus, only 53 participants have this measure. | Mean | Standard Deviation | None (Index) |
|
| Participants |
|
|
|
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |