Aldose Reductase Inhibitor for Diabetic Retinopathy Prevention
Data Collection
Cardiovascular Diseases+9
+ Diabetes Mellitus
+ Diabetic Angiopathies
Treatment Study
Summary
Study start date: August 1, 1983
Actual date on which the first participant was enrolled.This study is about testing an enzyme-blocking drug called Sorbinil in people with diabetes. The enzyme, aldose reductase (AR), is believed to cause complications in diabetes, such as cataracts and retinopathy. By blocking AR, Sorbinil may help prevent or slow down these complications. The study is particularly interested in diabetic retinopathy, a condition that affects the eyes and can lead to blindness. This research is important as it could potentially improve care for people with diabetes and reduce the risk of vision loss. Initially, participants in the study took a daily dose of 250 mg of Sorbinil. However, due to some serious allergic reactions, the dosage was changed to a gradual increase, starting from 25 mg and reaching 250 mg after a month. The study includes regular check-ups, with weekly visits for the first month, monthly visits for the next two months, and then every three months. Additional visits are required for those on the gradual dosage increase. During these visits, various tests are conducted, including eye examinations, heart health checks, and measurements of red blood cell sorbitol levels. Participants are also asked to note any signs of allergic reactions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 56 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Men and women eligible for the SRT had diabetes for 1 to 15 years and were between ages 18 and 56 at the time of enrollment. They had begun taking insulin before their 41st birthday. Their hemoglobin A1c value was within the diabetic range. On retinal examination, they showed no evidence of or only very mild retinopathy, with no more than five microaneurysms per eye. Women were postmenopausal, sterile, or had an IUD in place.