Diabetes MellitusPhase 2NCT04547439
Sleep, Diabetic Retinopathy and Melatonin
A Phase 2 study testing Melatonin in people with Diabetes Mellitus and Diabetic Retinopathy, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study explores the use of melatonin in patients with diabetic retinopathy Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
- 40-65 years of age
- Diabetic retinopathy of at least moderate degree
Who cannot join
- use of melatonin
- antidepressants or antipsychotics
- illicit drug use
- night shift work or travel beyond 2 time zones in the month before enrollment
- end stage renal disease requiring renal replacement therapy
- history of stroke or transient ischemic attacks
Show all 21Show fewer
- history of dementia or memory impairment
- uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)
- chronic obstructive pulmonary disease requiring oxygen
- severe chronic liver disease such as cirrhosis
- ongoing treatment for major medical problems such as cancer
- history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.
- Significant depressive symptoms
- untreated severe OSA (AHI≥ 30 events/hour),
- uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
- uncontrolled diabetes (A1C ≥ 11%),
- abnormal TSH
- abnormal liver function (AST or ALT>3x upper limits of normal
- use of sedatives and hypnotics.
- clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.
- hemoglobin <11.5 g/dL in women and <13.5 g/dL in men.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Sirimon Reutrakul, MD
About this study
Official title: Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
This study explores the use of melatonin in patients with diabetic retinopathy
Read the detailed description
This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Being tested
- Melatonin, Placebo
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin 3 mg will be taken nightly for 8 weeks
PlaceboOther
Placebo will be given nightly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Placebo Receives: Other: Placebo |
| Melatonin | Active comparator | Melatonin Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep pattern
Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days
Measured: 14 days
Melatonin and Cortisol Rhythm
Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start3 Feb 2021
- Primary completion2 Feb 2026
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, Sirimon Reutrakul, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547439
- Sponsor's protocol ID
- 2020-1052
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005 Feb;9(1):41-50. doi: 10.1016/j.smrv.2004.06.004.
PubMed 15649737Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.
PubMed 14655926Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet. 1995 Aug 26;346(8974):541-4. doi: 10.1016/s0140-6736(95)91382-3.
PubMed 7658780Raygan F, Ostadmohammadi V, Bahmani F, Reiter RJ, Asemi Z. Melatonin administration lowers biomarkers of oxidative stress and cardio-metabolic risk in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2019 Feb;38(1):191-196. doi: 10.1016/j.clnu.2017.12.004. Epub 2017 Dec 12.
PubMed 29275919
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
- ClinicalTrials.gov ID
- NCT04547439
- Acronym / sponsor ID
- 2020-1052
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the use of melatonin in patients with diabetic retinopathy
Detailed description
This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: PlaceboPlacebo |
| Melatonin | Active comparator | Drug: MelatoninMelatonin |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)
- 40-65 years of age
- Diabetic retinopathy of at least moderate degree
Key exclusion criteria (21 listed)
- use of melatonin
- antidepressants or antipsychotics
- illicit drug use
- night shift work or travel beyond 2 time zones in the month before enrollment
- end stage renal disease requiring renal replacement therapy
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 |
|---|---|---|
| MelatoninMelatonin 3 mg will be taken nightly for 8 weeks | Drug | Melatonin |
| PlaceboPlacebo will be given nightly for 8 weeks | Other | Control |
Primary outcome
Sleep pattern
Time frame: 14 days
Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days
Melatonin and Cortisol Rhythm
Time frame: 24 hours
Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 15649737Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005 Feb;9(1):41-50. doi: 10.1016/j.smrv.2004.06.004.
- Background: PubMed 14655926Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.
- Background: PubMed 7658780Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet. 1995 Aug 26;346(8974):541-4. doi: 10.1016/s0140-6736(95)91382-3.
- Background: PubMed 29275919Raygan F, Ostadmohammadi V, Bahmani F, Reiter RJ, Asemi Z. Melatonin administration lowers biomarkers of oxidative stress and cardio-metabolic risk in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2019 Feb;38(1):191-196. doi: 10.1016/j.clnu.2017.12.004. Epub 2017 Dec 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Diabetes Mellitus and Diabetic Retinopathy, run by University of Illinois Chicago 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 3 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sirimon Reutrakul (3129966060, sreutrak@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep pattern (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04547439, which also lists 4 linked publications.
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 21 Apr 2026.