Circadian Dysregulation, Diabetes, Sleep Deprivation
Conditions
Keywords
diabetes, sleep
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.
Interventions
None listed
Sponsors
Northwestern University
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Of 120 participants enrolled in the study, 56 were eligible, continued in the study and provided some data.
Participants by arm
| Arm | Count |
|---|---|
| Study Sample This is a cross-sectional study so there is only one group. | 56 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 17 |
| Overall Study | Lost to Follow-up | 47 |
Baseline characteristics
| Characteristic | Study Sample |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 8.4 |
| Body Mass Index (BMI), kg/m2 | 27.7 kg/m2 STANDARD_DEVIATION 5.3 |
| Duration of Rapid Eye Movement (REM) sleep (minutes) | 96.5 Minutes STANDARD_DEVIATION 49.1 |
| Duration of Stage 2 sleep (minutes) | 190.6 Minutes STANDARD_DEVIATION 77.4 |
| Duration of Stage 3 sleep (minutes) | 68.4 Minutes STANDARD_DEVIATION 30.7 |
| Estimated Insulin Resistance (HOMA index method) | 1.75 None (Index) STANDARD_DEVIATION 1.82 |
| Fasting glucose levels (mg/dl) | 86.8 mg/dl STANDARD_DEVIATION 6.3 |
| Habitual Sleep Duration (hours) | 402 minutes STANDARD_DEVIATION 39 |
| Habitual sleep efficiency (% of sleep period sleeping) | 90.8 percentage STANDARD_DEVIATION 3.5 |
| Habitual sleep start time (clock time) | 0.27 Hours after midnight STANDARD_DEVIATION 1.51 |
| Oral Disposition Index at 30 minutes | 11.5 None (Index) STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
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.
Time frame: baseline
Population: Three participants did not have adequate glucose and/or insulin values to calculate the disposition index.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Sample | Oral Disposition Index | 11.5 None (Index) | Standard Deviation 12.7 |
Comparison: The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.p-value: 0.1395% CI: [-0.173, 0.023]Regression, Linear
Comparison: The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.p-value: 0.8395% CI: [-0.95, 1.19]Regression, Linear
Comparison: The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.p-value: 0.3995% CI: [-0.166, 0.66]Regression, Linear
Comparison: The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.p-value: 0.1195% CI: [-0.129, 0.014]Regression, Linear