NCT03188263: ML

Morning Light Treatment to Improve Glucose Metabolism

Completed NA Results posted Last updated 20 January 2021

What this trial tests

NA trial testing Bright Light in PreDiabetes in 10 participants. Completed in 31 December 2019.

Timeline

5 September 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	10
Start date	5 September 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Bright Light
• Dim Light

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →
• Circadian Dysregulation — all drugs for Circadian Dysregulation →

Sponsor

Northwestern University

Who can join

Adults 35 to 70, any sex, with PreDiabetes or Circadian Dysregulation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT) Primary · Change from baseline to after 4 weeks of light treatment

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.

Group	Value	95% CI
Bright Light	-11.3	± 11.0

Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO) Secondary · Change from baseline to after 4 weeks of light treatment.

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.

Group	Value	95% CI
Bright Light	-0.6	± 1.9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.