About this trial
N-acetylcysteine (NAC) emerges as a crucial factor in mitigating oxidative stress and inhibiting vascular endothelial activation in diabetic patients, through its effect on VEGF expression as VEGF is involved in the development of diabetic microvascular complications through the promotion of retinal angiogenesis and increased vascular permeability.
It was reported in the literature that NAC administration was safe in several studies. It was shown that the dose of 1200 mg is safe and effective.
To the best of our knowledge, the present study is the first to be designed to evaluate the effect of N-acetyl cysteine on diabetic retinopathy in type 2 diabetic patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with type 2 diabetes mellitus
Patients with mild to moderate degrees of diabetic retinopathy
Patients over the age of 18 and under the age of 70 years
Patients who voluntarily give their informed consent
Disqualifiers
• Patients with any other ophthalmologic conditions than diabetic retinopathy
Patients with previous surgical or laser treatment
Pregnant or breastfeeding patients
Patients using antioxidants.
Trial design
Parallel
Treatments tested in this trial
N Acetyl cysteine, 1200mg (high dose)
DrugN-acetylcysteine (NAC), alternatively referred to as N-acetyl-L-cysteine, is an acetylated version of the amino acid L-cysteine, with the chemical formula C5H9NO3S. Initially employed to thin stubborn bronchial secretions, NAC has found application in treating chronic bronchitis and various pulmonary ailments to address thick mucus. Remarkably, NAC functions as both a direct antioxidant and a precursor to glutathione. It effectively eliminates reactive oxygen species (ROS), such as hydroxyl radicals, hypochlorous acid, and hydrogen peroxide. These ROS have the potential to oxidize lipids, proteins, and DNA, generating carbon-centered radicals along the DNA backbone, ultimately leading to cell death.The thiol group in NAC is responsible for its antioxidant properties. Additionally, NAC can be metabolized into cysteine, a key building block in the synthesis of glutathione. Glutathione plays a crucial role as an antioxidant, protecting cellular components from damage caused by ROS(
Treatment groups
Trial outcomes
Primary outcomes
Changes in glutathione peroxidase levels
Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.
Sponsors and contacts
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Ain Shams University
Lead sponsor
National Institute of Diabetes and Endocrinology, Egypt
Collaborator