Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
NCT Number: NCT03188263
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.
Looking for future studies?
Notify Me35 year–70 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
34 subjects (50% female, age 40-65 y)
Subjects will be:
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
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.
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
Time frame: 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.
Time frame: 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.
Northwestern University
Other
Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
Acronym: ML
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07618663
Diabetes Mellitus, Endocrine System Diseases
Lahore, Shaikhupura, Pakistan
View Trial DetailsNCT07710898
Diabete Mellitus, Diabetes Mellitus
Lahore, Pakistan
View Trial DetailsNCT06268990
Body Weight, Diabetes
Graz, Austria
View Trial DetailsNCT05648383
Body Weight, Cardiovascular Diseases
Tirana, Rruga E Dibrës, Albania
View Trial Details