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Completed NCT06183476

Circadian Amplification in Diabetic Retinopathy

Conditions: Diabetic Retinopathy

Sex: All
Ages: 40 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 8
Sponsor: University of Illinois at Chicago

Location: University of Illinois at Chicago Chicago Illinois

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 subjective sleep parameters, evening salivary cortisol and melatonin levels, and glucose parameters from continuous glucose monitoring

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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%)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06183476). StuddyBuddy aggregates publicly available trial information.