Morning Light Treatment to Improve Glucose Metabolism

Completed · Not applicable · Has a placebo group

Conditions studied: PreDiabetes, Circadian Dysregulation

In brief

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.

Key facts

Study ID

NCT03188263

Run by

Northwestern University

People needed

10

Starts

2017-09-05

Expected to finish

2019-12-31

Last updated by the study team

2021-01-20

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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