Sleep, Diabetic Retinopathy and Melatonin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Illinois at Chicago
About this trial
This study explores the use of melatonin in patients with diabetic retinopathy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
use of melatonin
antidepressants or antipsychotics
illicit drug use
night shift work or travel beyond 2 time zones in the month before enrollment
Trial design
Design model
Parallel
Treatments tested in this trial
Melatonin
DrugMelatonin 3 mg will be taken nightly for 8 weeks
Placebo
Other interventionPlacebo will be given nightly for 8 weeks
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: MelatoninActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep pattern
Sleep pattern: Sleep duration and sleep efficiency will be assessed by wrist actigraphy, to be worn by the participants for 14 days
Time frame
14 days2
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
Time frame
24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
University of Chicago
Collaborator
Source ClinicalTrials.gov