Status:
COMPLETED
Circadian Amplification in Diabetic Retinopathy
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The outcomes of interest are objective and subjecti...
Detailed Description
This study will test the effects of a 6-week comprehensive circadian optimization intervention Amplify-RHYTHM in patients with diabetic retinopathy. The two main components of the intervention are tim...
Eligibility Criteria
Inclusion
- type 2 diabetes
- a history of at least moderate non-proliferative diabetic retinopathy
- would like to improve sleep
- own a smartphone compatible with fitbit.
Exclusion
- Use of melatonin
- Use of antipsychotics
- Use of more than one antidepressant. The dose of which needs to be stable for 6 weeks.
- 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.
- Regular use of sedatives and hypnotics (\>2 times/ month).
- 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.
- Significant depressive symptoms as assessed by PHQ-8 questionnaire (score \>14)
- No health insurance coverage
- History of untreated severe OSA.
- Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
- Uncontrolled diabetes (A1C ≥ 11%)
Key Trial Info
Start Date :
March 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06183476
Start Date
March 20 2024
End Date
January 10 2025
Last Update
August 11 2025
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612