Morning Light Treatment to Improve Glucose Metabolism

NCT ID: NCT03188263

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2019-12-31

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.

Conditions

PreDiabetes; Circadian Dysregulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bright Light

Irradiance is 230 μW/m2 and lux is 500 lux.

Group Type: EXPERIMENTAL

Bright Light

Intervention Type: OTHER

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.

Dim Light

irradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux

Group Type: PLACEBO_COMPARATOR

Dim Light

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Kristen Knutson

Associate Professor, Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen Knutson, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

STU00204710

Identifier Type: -

Identifier Source: org_study_id