PreDiabetes Clinical Trial
— MLOfficial title:
Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
Verified date | December 2020 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Memorial Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Rush University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Change from baseline to after 4 weeks of light treatment | |
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. | Change from baseline to after 4 weeks of light treatment. |
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