An interventional study of Bright Light and Dim Light in PreDiabetes and Circadian Dysregulation, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
The primary purpose of this pilot study is to test a novel head worn light device (Re-Timer®) as an intervention to improve glucose metabolism in people with prediabetes. The hypothesis is that morning light treatment will improve glucose metabolism. This is a pilot study and the data from this project will be used to develop a larger clinical trial.
This is a pilot study to determine whether light treatment can improve glucose metabolism in people with prediabetes. Individuals will be asked to complete a baseline session with one-week of at-home sleep monitoring followed by a 24-hour stay in the clinical research unit. During this stay, we will sample saliva in the evening to measure melatonin to estimate the timing of the internal biological clock ("circadian phase") and then we will perform a 3-hour oral glucose tolerance test in the morning to estimate markers of glucose metabolism, including insulin sensitivity. The participants will then be given a light device and instructed on its use. They will use the device for four weeks and visit our laboratory every week for a check-in. At the end of the four weeks, they will repeat the 24-hour stay in the clinical research unit.
89 studies on the registry are indexed under Chronobiology Disorders; 21 are open to participants now.
This study's enrollment of 10 is below the median of 65 across 58 interventional studies indexed under Chronobiology Disorders.
Browse Chronobiology Disorders studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: 34 subjects (50% female, age 40-65 y)
Subjects will be:
The laboratory sessions will occur during women's follicular phase or women will be postmenopausal (≥6 months since last menses).
Subjects will be scheduled to participate ≥ 1 month from travel outside the central time zone, and during a time with minimal special events.
Exclusion Criteria:
Irradiance is 230 μW/m2 and lux is 500 lux.
Other: Bright Light
irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux
Other: Dim Light
1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux.
1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux
Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT)
The OGTT is a 3-hour procedure measuring blood glucose levels after the patient has consumed a 75-gram dextrose solution at -15 min, 0 min, 30 min, 60 min, 90 min, 120 min, and 180 min intervals. Total area-under-the-curve of glucose levels is calculated.
Time frame: Change from baseline to after 4 weeks of light treatment
Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO)
The DLMO is measured via saliva samples collected during laboratory sessions. A sample is collected every half hour until bedtime starting 6.5 hours before habitual bedtime, and conducted in dim light setting to identify the point when melatonin starts being released.
Time frame: Change from baseline to after 4 weeks of light treatment.
| Milestone | Bright Light | Dim Light |
|---|---|---|
| Started | 10 | 0 |
| Completed | 6 | 0 |
| Not completed | 4 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Physician decision | 1 | 0 |
The OGTT is a 3-hour procedure measuring blood glucose levels after the patient has consumed a 75-gram dextrose solution at -15 min, 0 min, 30 min, 60 min, 90 min, 120 min, and 180 min intervals. Total area-under-the-curve of glucose levels is calculated.
| mg*h/dL | Bright Light | Dim Light |
|---|---|---|
| Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT) | -11.3 ± 11.0 | — |
The DLMO is measured via saliva samples collected during laboratory sessions. A sample is collected every half hour until bedtime starting 6.5 hours before habitual bedtime, and conducted in dim light setting to identify the point when melatonin starts being released.
| hours | Bright Light | Dim Light |
|---|---|---|
| Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO) | -0.6 ± 1.9 | — |
Collected over 4 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bright Light | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Dim Light | — | — | — |
There were no participants enrolled into the dim light condition.
| Age, Categorical(Participants) | Bright Light | Dim Light | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 9 | — | 9 |
| >=65 years | 1 | — | 1 |
| Age, Continuous(years) | Bright Light | Dim Light | Total |
|---|---|---|---|
| Mean | 52.1 ± 8.0 | — | 52.1 ± 8.0 |
| Sex: Female, Male(Participants) | Bright Light | Dim Light | Total |
|---|---|---|---|
| Female | 6 | — | 6 |
| Male | 4 | — | 4 |
| Ethnicity (NIH/OMB)(Participants) | Bright Light | Dim Light | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | — | 1 |
| Not Hispanic or Latino | 8 | — | 8 |
| Unknown or Not Reported | 1 | — | 1 |
| Race (NIH/OMB)(Participants) | Bright Light | Dim Light | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 7 | — | 7 |
| White | 2 | — | 2 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 1 | — | 1 |
| Region of Enrollment(participants) | Bright Light | Dim Light | Total |
|---|---|---|---|
| United States | 10 | — | 10 |
| Hemoglobin A1c (%), Continuous(% of hemoglobin bound to glucose) | Bright Light | Dim Light | Total |
|---|---|---|---|
| Mean | 6.0 ± 0.2 | — | 6.0 ± 0.2 |
| Body mass index(kg/m^2) | Bright Light | Dim Light | Total |
|---|---|---|---|
| Mean | 34.5 ± 7.1 | — | 34.5 ± 7.1 |
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