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Morning Light Treatment to Improve Glucose Metabolism (ML)

Primary Purpose

PreDiabetes, Circadian Dysregulation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bright Light

Dim Light

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring diabetes, sleep, circadian rhythm, light treatment

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright Light

Dim Light

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03188263

First Posted

June 1, 2017

Last Updated

December 28, 2020

Sponsor

Northwestern University

Collaborators

Rush University

1. Study Identification

Unique Protocol Identification Number

NCT03188263

Brief Title

Morning Light Treatment to Improve Glucose Metabolism

Acronym

Official Title

Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

September 5, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Rush University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes, Circadian Dysregulation

Keywords

diabetes, sleep, circadian rhythm, light treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

half will receive active light treatment device, the other half will receive a placebo device

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bright Light

Arm Type

Experimental

Arm Description

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

Arm Title

Dim Light

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Bright Light

Intervention Description

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

Intervention Name(s)

Dim Light

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT)

Description

Time Frame

Change from baseline to after 4 weeks of light treatment

Secondary Outcome Measure Information:

Title

Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO)

Description

Time Frame

Change from baseline to after 4 weeks of light treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristen Knutson, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Morning Light Treatment to Improve Glucose Metabolism

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