NCT06183476Completed
Circadian Amplification in Diabetic Retinopathy
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 13 Dec 2023
- Start date
- 20 Mar 2024
- Primary completion date
- 10 Jan 2025
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Diabetic eye disease
- NCT number
- NCT06183476
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 20 Mar 2024 to the primary completion date, 10 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- illicit drug use
- night shift work or travel beyond 2 time zones in the month before enrollment
Other illness
- 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.
- 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.
- History of untreated severe OSA.
- Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg),
- Uncontrolled diabetes (A1C ≥ 11%)
Other
- Use of melatonin
- Use of antipsychotics
- Use of more than one antidepressant. The dose of which needs to be stable for 6 weeks.
- Regular use of sedatives and hypnotics (\>2 times/ month).
- Significant depressive symptoms as assessed by PHQ-8 questionnaire (score \>14)
- No health insurance coverage
Who the study is looking for
- type 2 diabetes
- a history of at least moderate non-proliferative diabetic retinopathy
- would like to improve sleep
- own a smartphone compatible with fitbit.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
Related publications
- Circadian rhythm amplification in diabetic retinopathy: a pilot study.Sleep Adv · 2026 · PMID 42741696
This page is information, not medical advice. Discuss any trial with your doctor.