[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04547439":3,"trial-entities:NCT04547439":118,"trial-summary:NCT04547439":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":81,"locations":84,"central_contacts":97,"overall_officials":102,"references":103,"see_also_links":117},"NCT04547439","2020-1052","Sleep, Diabetic Retinopathy and Melatonin","Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation","RECRUITING","2026-06","2026-04","2026-04-21","2021-02-03","University of Illinois at Chicago","OTHER",true,"This study explores the use of melatonin in patients with diabetic retinopathy","This is a randomized controlled study using melatonin for 8 weeks in patients with diabetic retinopathy on outcomes of sleep and circadian regulation",[19,20],"Diabetes Mellitus","Diabetic Retinopathy",[],"INTERVENTIONAL",[24],"PHASE2",{"count":26,"type":27},42,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Melatonin","Melatonin 3 mg will be taken nightly for 8 weeks",[31],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Placebo","Placebo will be given nightly for 8 weeks",[38],"Control",[40,44],{"measure":41,"description":42,"timeFrame":43},"Sleep pattern","Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days","14 days",{"measure":45,"description":46,"timeFrame":47},"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","24 hours",[],"ALL","40 Years","65 Years",false,{"inclusion":54,"exclusion":58,"raw_text":80},[55,56,57],"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",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"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","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\u002Fhour),","uncontrolled hypertension (blood pressure ≥ 160\u002F100 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 \\\u003C11.5 g\u002FdL in women and \\\u003C13.5 g\u002FdL in men.","Inclusion Criteria:\n\n* Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)\n* 40-65 years of age\n* Diabetic retinopathy of at least moderate degree\n\nExclusion Criteria:\n\n* use of melatonin\n* antidepressants or antipsychotics\n* illicit drug use\n* night shift work or travel beyond 2 time zones in the month before enrollment\n* end stage renal disease requiring renal replacement therapy\n* history of stroke or transient ischemic attacks\n* history of dementia or memory impairment\n* uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)\n* chronic obstructive pulmonary disease requiring oxygen\n* severe chronic liver disease such as cirrhosis\n* ongoing treatment for major medical problems such as cancer\n* history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.\n* Significant depressive symptoms\n* untreated severe OSA (AHI≥ 30 events\u002Fhour),\n* uncontrolled hypertension (blood pressure ≥ 160\u002F100 mmHg),\n* uncontrolled diabetes (A1C ≥ 11%),\n* abnormal TSH\n* abnormal liver function (AST or ALT\\>3x upper limits of normal\n* use of sedatives and hypnotics.\n* 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.\n* hemoglobin \\\u003C11.5 g\u002FdL in women and \\\u003C13.5 g\u002FdL in men.",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":94},"Chicago","Illinois","60612","United States",[91],{"name":92,"role":93},"Sirimon Reutrakul, MD","CONTACT",{"lat":95,"lon":96},41.85003,-87.65005,[98],{"name":99,"role":93,"phone":100,"email":101},"Sirimon Reutrakul","3129966060","sreutrak@uic.edu",[],[104,108,111,114],{"pmid":105,"type":106,"citation":107},"15649737","BACKGROUND","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\u002Fj.smrv.2004.06.004.",{"pmid":109,"type":106,"citation":110},"14655926","Singer 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\u002Fsleep\u002F26.7.893.",{"pmid":112,"type":106,"citation":113},"7658780","Garfinkel 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\u002Fs0140-6736(95)91382-3.",{"pmid":115,"type":106,"citation":116},"29275919","Raygan 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\u002Fj.clnu.2017.12.004. Epub 2017 Dec 12.",[],{"nct_id":4,"conditions":119,"biomarkers":120},[19,20],[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is a randomized controlled study, meaning participants will be randomly assigned to receive either melatonin or a placebo (an inactive substance). The study plans to enroll 42 participants.","completed","Melatonin for Sleep and Diabetic Retinopathy","This study is looking at whether taking melatonin can help people with type 2 diabetes and diabetic retinopathy (damage to the blood vessels in the retina, the light-sensitive tissue at the back of the eye). We want to see if melatonin affects sleep patterns and the body's natural rhythms of melatonin and cortisol (a stress hormone). You could join if you are 40-65 years old, have type 2 diabetes, and at least moderate diabetic retinopathy. You cannot join if you already use melatonin, take certain medications, or work night shifts. The study plans to enroll 42 participants. The current status of the study is unclear.","Sleep patterns are measured at 14 days, and melatonin and cortisol rhythms are measured at 24 hours.",105,"You would take either melatonin 3 mg or a placebo nightly for 8 weeks. Sleep patterns will be measured at 14 days, and melatonin and cortisol rhythms will be measured at 24 hours.","Not stated in the trial record.",[31],"v2"]