RECRUITINGPhase 2INTERVENTIONAL
Sleep, Diabetic Retinopathy and Melatonin
Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation
About This Trial
This study explores the use of melatonin in patients with diabetic retinopathy
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 Should NOT Join This Trial:
- 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/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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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/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.
Treatments Being Tested
DRUG
Melatonin
Melatonin 3 mg will be taken nightly for 8 weeks
OTHER
Placebo
Placebo will be given nightly for 8 weeks
Locations (1)
University of Illinois at Chicago
Chicago, Illinois, United States