Morning Light Treatment to Improve Glucose Metabolism
Status: | Recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 40 - 65 |
Updated: | 2/22/2018 |
Start Date: | September 5, 2017 |
End Date: | May 31, 2019 |
Contact: | Matthew Brenner-Jedwabnik, MPH |
Email: | matthew.brenner-jedwabnik@northwestern.edu |
Phone: | 3125034965 |
Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
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.
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.
Inclusion Criteria: 34 subjects (50% female, age 40-65 y)
Subjects will be:
- Prediabetic (HbA1c 5.7% to <6.5%)
- obese (BMI>30 kg/m2)
- have significant circadian misalignment (social jet lag ≥ 2 h, associated with higher
BMI [2] and higher HbA1c [3])
- be free of moderate to severe obstructive sleep apnea (apnea-hypopnea index<15).
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 40-65 years (we will not enroll anyone older than 65 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.
We found this trial at
1
site
251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Kristen Knutson, PhD
Phone: 312-503-1526
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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