Sleep, Diabetic Retinopathy and Melatonin
Study Details
Study Description
Brief Summary
This study explores the use of melatonin in patients with diabetic retinopathy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control Placebo |
Other: Placebo
Placebo will be given nightly for 8 weeks
|
| Active Comparator: Melatonin Melatonin |
Drug: Melatonin
Melatonin 3 mg will be taken nightly for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Sleep pattern [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 [24 hours]
Melatonin and cortisol pattern (peak times of the levels, dim light melatonin onset) will be assessed from 24 hour blood sampling
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
- University of Chicago
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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/j.clnu.2017.12.004. Epub 2017 Dec 12.
- 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.
- 2020-1052