PreDiabetesMLNCT03188263
Morning Light Treatment to Improve Glucose Metabolism
A study testing Bright Light and Dim Light in people with PreDiabetes and Circadian Dysregulation, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Circadian Dysregulation
- What is being tested?
- Bright Light and Dim Light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
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.
Read the 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
- Being tested
- Bright Light, Dim Light
- Keywords
- diabetes, sleep, circadian rhythm, light treatment
- Medical subject headings
- Prediabetic State, Chronobiology Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright LightOther
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 LightOther
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
| Study group | Role | What they receive |
|---|---|---|
| Bright Light | Experimental | Irradiance is 230 μW/m2 and lux is 500 lux. Receives: 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 Receives: Other: Dim Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to after 4 weeks of light treatment
Secondary outcomes (1)
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.
Measured: Change from baseline to after 4 weeks of light treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start5 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- half will receive active light treatment device, the other half will receive a placebo device
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University
- Responsible party
- Principal investigator, Kristen Knutson, Northwestern University
- Investigators
- Kristen Knutson, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188263
- Sponsor's protocol ID
- STU00204710
- Acronym
- ML
- Status last verified
- Dec 2020
- First submitted
- 1 Jun 2017
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03188263
- Acronym / sponsor ID
- ML / STU00204710
- Conditions
- PreDiabetes, Circadian Dysregulation
- Keywords
- diabetes, sleep, circadian rhythm, light treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Rush University
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 29 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- half will receive active light treatment device, the other half will receive a placebo device
| Arm | Type | Receives |
|---|---|---|
| Bright Light | Experimental | Other: Bright LightIrradiance is 230 μW/m2 and lux is 500 lux. |
| Dim Light | Placebo comparator | Other: Dim Lightirradiance is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light1 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. | Other | Bright Light |
| Dim Light1 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 | Other | Dim Light |
Primary outcome
Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT)
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.
1 secondary outcome
Changes in Circadian Phase Measured by Dim Light Melatonin Onset (DLMO)
Time frame: Change from baseline to after 4 weeks of light treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Knutson, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light and Dim Light in people with PreDiabetes and Circadian Dysregulation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glucose Levels (Area-under-the-curve) Measured by Performance on Oral Glucose Tolerance Test (OGTT) (time frame: Change from baseline to after 4 weeks of light treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.