Diabetes Mellitus, Diabetic Retinopathy
Conditions
Brief summary
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
Interventions
DRUGMelatonin
Melatonin 3 mg will be taken nightly for 8 weeks
OTHERPlacebo
Placebo will be given nightly for 8 weeks
Sponsors
University of Illinois at Chicago
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and investigators are blinded.
Intervention model description
Double blinded randomized controlled study
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTSirimon Reutrakul
Outcome results
None listed