Morning Light Treatment to Improve Glucose Metabolism

NCT03188263 | Completed Results DMC

• 1 other identifier: STU00204710
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Circadian Dysregulation

Keywords

diabetes; sleep; circadian rhythm; light treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to after 4 weeks of light treatment

Secondary Outcomes (1)

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

  Change from baseline to after 4 weeks of light treatment.

Study Arms (2)

Bright Light

EXPERIMENTAL

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

Other: Bright Light

Dim Light

PLACEBO COMPARATOR

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

Other: Dim Light

Interventions

Bright Light 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.

Bright Light

Dim Light 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

Dim Light

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Northwestern University: lead
• Rush University: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prediabetic State; Chronobiology Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases

Limitations and Caveats

Our planned enrollment goal was 14 participants in each group and therefore we were underpowered in the bright light group to detect changes in all outcome measures. Further, we were not able to perform secondary analyses, which included between group comparisons.

Results Point of Contact

• Title: Kristen Knutson
• Organization: Northwestern University

kristen.knutson@northwestern.edu

312-503-1526

Study Officials

• Kristen Knutson, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine

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

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 15, 2017
• Study Start: September 5, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 20, 2021
• Results First Posted: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)