PreDiabetes, Circadian Dysregulation
Conditions
Keywords
diabetes, sleep, circadian rhythm, light treatment
Brief summary
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.
Detailed description
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.
Interventions
OTHERBright 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.
OTHERDim 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
Sponsors
Rush University
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
half will receive active light treatment device, the other half will receive a placebo device
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
34 subjects (50% female, age 40-65 y) Subjects will be: * Prediabetic (HbA1c 5.7% to \<6.5%) * overweight or obese (BMI\>25 kg/m2) * be free of moderate to severe obstructive sleep apnea (apnea-hypopnea index\<30). 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
* Women who are pregnant, planning on becoming pregnant, or are breastfeeding. * Women on oral contraceptives or hormone replacement therapy will be excluded (alters OGTT and melatonin). * Men and women who have a child at home that does not sleep through the night will be excluded. * Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners are also excluded. * History of any form of diabetes, including use of diabetes medications * Age outside 35-70 years (we will not enroll anyone older than 70 years because of a reduced response to light). * Smokers * Shift workers * Failed urine drug test (drugs of abuse, nicotine) * Eye disease/photosensitizing medications * Sleep medications, diagnosed sleep disorders (history of treatment may affect glucose metabolism), * Daily beta-blocker, NSAID or melatonin use (confounds DLMO) * History of psychiatric disorders (confounds effect of light treatment, per relevant items from Mood Disorder, Psychotic Screening and Substance Use Disorders Modules of the Structured Clinical Interview for DSM-IV Axis I Disorders - Non-Patient Edition (SCID-IV/NP) to screen for schizophrenia, bipolar depression, substance abuse, suicidal ideation, obsessive compulsive disorder, PTSD), depressive symptoms using the Center for Epidemiologic Studies - Depression (CES-D) scale * Irregular menses * History of cardiovascular disease (excluding hypertension), endocrine, kidney, gastrointestinal or liver disorder, seizures, and cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT) | Change from baseline to after 4 weeks of light treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO) | Change from baseline to after 4 weeks of light treatment. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Bright Light | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants |
| Age, Continuous | 52.1 years STANDARD_DEVIATION 8 | 52.1 years STANDARD_DEVIATION 8 |
| Body mass index | 34.5 kg/m^2 STANDARD_DEVIATION 7.1 | 34.5 kg/m^2 STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Hemoglobin A1c (%), Continuous | 6.0 % of hemoglobin bound to glucose STANDARD_DEVIATION 0.2 | 6.0 % of hemoglobin bound to glucose STANDARD_DEVIATION 0.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants |
| Region of Enrollment United States | 10 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 0 |
| other Total, other adverse events | 0 / 10 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 0 |
Outcome results
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.
Time frame: Change from baseline to after 4 weeks of light treatment
Population: There were no participants enrolled into the dim light condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light | 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 |
Comparison: The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.p-value: 0.046Sign test
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light | Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO) | -0.6 hours | Standard Deviation 1.9 |
Comparison: The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.p-value: 0.35Sign test