Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rush University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light | Experimental | Irradiance is 230 μW/m2 and lux is 500 lux. |
|
| Dim Light | Placebo Comparator | irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to after 4 weeks of light treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to after 4 weeks of light treatment. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristen Knutson, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bright Light | Irradiance is 230 μW/m2 and lux is 500 lux. Bright 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. |
| FG001 | Dim Light | irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux Dim Light: 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There were no participants enrolled into the dim light condition.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bright Light | Irradiance is 230 μW/m2 and lux is 500 lux. Bright 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. |
| BG001 | Dim Light |
| 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 | 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. | There were no participants enrolled into the dim light condition. | Posted | Mean | Standard Deviation | mg*h/dL | Change from baseline to after 4 weeks of light treatment |
|
4 weeks
There were no participants enrolled in the dim light group and therefore there was no one at risk.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bright Light | Irradiance is 230 μW/m2 and lux is 500 lux. Bright 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. |
Not provided
Not provided
Our planned enrollment goal was 14 participants in each group and therefore we were underpowered in the bright light group to detect changes in all outcome measures. Further, we were not able to perform secondary analyses, which included between group comparisons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Knutson | Northwestern University | 312-503-1526 | kristen.knutson@northwestern.edu |
Not provided
| 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 3, 2018 | Dec 1, 2020 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D021081 | Chronobiology Disorders |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
half will receive active light treatment device, the other half will receive a placebo device
Not provided
Not provided
Not provided
| Dim Light | Other | 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 |
|
irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux Dim Light: 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c (%), Continuous | Mean | Standard Deviation | % of hemoglobin bound to glucose |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Dim Light |
irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux Dim Light: 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 |
|
|
|
| Secondary | 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. | There were no participants enrolled into the dim light condition. In addition, one participant in the bright light condition was missing a valid DLMO measurement. | Posted | Mean | Standard Deviation | hours | Change from baseline to after 4 weeks of light treatment. |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Dim Light | irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux Dim Light: 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 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D009422 | Nervous System Diseases |