N/A
N=10
Morning Light Treatment to Improve Glucose Metabolism
PreDiabetes · Circadian Dysregulation
Bottom Line
View on ClinicalTrials.gov: NCT03188263 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT) — -11.3 mg*h/dL — p=.046
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bright Light (Other); Dim Light (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT) |
-11.3 | .046 sig |
| SECONDARY Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO) |
-0.6 | .35 |
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.
Eligibility Criteria
Inclusion Criteria: 34 subjects (50% female, age 40-65 y)
Subjects will be:
- Prediabetic (HbA1c 5.7% to 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.
Data sourced from ClinicalTrials.gov (NCT03188263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.