Trial Outcomes & Findings for Morning Light Treatment to Improve Glucose Metabolism (NCT NCT03188263)
NCT ID: NCT03188263
Last Updated: 2021-01-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Change from baseline to after 4 weeks of light treatment
Results posted on
2021-01-20
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
0
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Morning Light Treatment to Improve Glucose Metabolism
Baseline characteristics by cohort
| Measure |
Bright Light
n=10 Participants
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.
|
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
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
—
|
9 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
—
|
52.1 years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
—
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
—
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
—
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
—
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
—
|
10 participants
n=206 Participants
|
|
Hemoglobin A1c (%), Continuous
|
6.0 % of hemoglobin bound to glucose
STANDARD_DEVIATION 0.2 • n=99 Participants
|
—
|
6.0 % of hemoglobin bound to glucose
STANDARD_DEVIATION 0.2 • n=206 Participants
|
|
Body mass index
|
34.5 kg/m^2
STANDARD_DEVIATION 7.1 • n=99 Participants
|
—
|
34.5 kg/m^2
STANDARD_DEVIATION 7.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to after 4 weeks of light treatmentPopulation: There were no participants enrolled into the dim light condition.
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.
Outcome measures
| Measure |
Bright Light
n=6 Participants
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.
|
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
|
|---|---|---|
|
Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT)
|
-11.3 mg*h/dL
Standard Deviation 11.0
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to after 4 weeks of light treatment.Population: 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.
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.
Outcome measures
| Measure |
Bright Light
n=5 Participants
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.
|
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
|
|---|---|---|
|
Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO)
|
-0.6 hours
Standard Deviation 1.9
|
—
|
Adverse Events
Bright Light
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dim Light
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place