Aldose Reductase Inhibitor for Diabetic Retinopathy Prevention
Collecte de données
Maladies Cardiovasculaires+9
+ Diabète Mellitus
+ Angiopathies diabétiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1983
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 56 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.