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Melatonin for Diabetic Retinopathy

Phase 2

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diabetic retinopathy of at least moderate degree

Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial looks at whether melatonin can help improve symptoms in patients with diabetic retinopathy.

Who is the study for?

This trial is for people aged 40-65 with Type 2 diabetes and moderate diabetic retinopathy. Candidates must not have severe memory issues, major untreated diseases like cancer or heart failure, uncontrolled blood pressure or diabetes, recent severe hypoglycemia, certain eye conditions, or be using melatonin or specific psychiatric drugs.Check my eligibility

What is being tested?

The study tests if melatonin can help patients with diabetic retinopathy. Participants will either receive melatonin or a placebo (a substance with no active drug). The goal is to see if there's any improvement in their condition compared to those who don't take the real medication.See study design

What are the potential side effects?

While the side effects of melatonin are generally mild and may include drowsiness, headache, dizziness, or nausea; this trial will monitor participants closely for any unexpected reactions due to their specific health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate or worse diabetic eye disease.

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I have type 2 diabetes or my A1C level is 6.5% or higher.

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I am between 40 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Melatonin and Cortisol Rhythm

Sleep pattern

Trial Design

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Placebo

Group II: MelatoninActive Control1 Intervention

Melatonin

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

607 Previous Clinical Trials

1,559,319 Total Patients Enrolled

1 Trials studying Diabetic Retinopathy

30 Patients Enrolled for Diabetic Retinopathy

University of ChicagoOTHER

1,002 Previous Clinical Trials

817,814 Total Patients Enrolled

Media Library

Diabetic Retinopathy Research Study Groups: Control, Melatonin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any other research done concerning the efficacy of Control?

"Currently, 24 clinical trials are in progress to research Control. Of these ongoing studies, 4 have reached Phase 3 development. While the primary location of study is Houston, Texas, a total of 25 sites across the nation are hosting investigations into this treatment."

Answered by AI

How many individuals will be enrolled in this trial?

"Affirmative. Per the details posted on clinicaltrials.gov, this study is actively seeking participants and was originally published on February 3rd 2021 with a most recent update dated May 16th 2022. Currently there are 36 spots to be filled at one medical centre."

Answered by AI

Has this type of clinical trial been attempted before?

"Control has been clinically studied since 2007, when Eli Lilly and Company launched the first of 20 trials. Subsequently granted N/A approval, there are currently 24 different studies involving Control taking place in 12 cities across 9 countries."

Answered by AI

Does this research program include individuals who are over forty years of age?

"This study seeks participants aged 40 to 65 years of age."

Answered by AI

What criteria must participants fulfill to be accepted in this research project?

"The current clinical trial is open to 36 individuals aged 40-65 with diabetic retinopathy. To be eligible, participants must meet the following age criteria: being between 40 and 65 years old."

Answered by AI

Is recruitment currently underway for this experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial - first published 2/3/2021 and updated 5/16/2022 - is presently in search of 36 patients from a single site."

Answered by AI

Is Control a dependable option for individuals?

"With only preliminary evidence of its safety, our team has assigned Control a score of 2 on the scale. As this is not yet a Phase 3 trial, there is no proof that it can produce any desired effect."

Answered by AI

Recent research and studies

Sleep Medicine ReviewsJournal

Effects of Exogenous Melatonin on Sleep: A Meta-analysis

Brzezinski, Amnon, Mark G. Vangel, Richard J. Wurtman, Gillian Norrie, Irina Zhdanova, Abraham Ben-Shushan, and Ian Ford. 2005. “Effects of Exogenous Melatonin on Sleep: A Meta-analysis”. Sleep Medicine Reviews. Elsevier BV. doi:10.1016/j.smrv.2004.06.004.

SleepJournal

A Multicenter, Placebo-controlled Trial of Melatonin for Sleep Disturbance in Alzheimer's Disease

Singer, Clifford, Rochelle E. Tractenberg, Jeffrey Kaye, Kim Schafer, Anthony Gamst, Michael Grundman, Ronald Thomas, and Leon J. Thal. 2003. “A Multicenter, Placebo-controlled Trial of Melatonin for Sleep Disturbance in Alzheimer's Disease”. Sleep. Oxford University Press (OUP). doi:10.1093/sleep/26.7.893.

The LancetJournal

Improvement of Sleep Quality in Elderly People by Controlled-release Melatonin

Garfinkel, D, M Laudon, D Nof, and N Zisapel. 1995. “Improvement of Sleep Quality in Elderly People by Controlled-release Melatonin”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(95)91382-3.

Clinical NutritionJournal