To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • N Acetyl cysteine, 1200mg (high dose)

    Drug

    N-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

76 Participants
are divided into 2 treatment groups
Group A: NPDR patients will receive placebo for three months.No intervention 0 interventions
Group B: NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in glutathione peroxidase levels

Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.

Time frame
will be measured at time 0 and after 3 months of taking n acetyl cysteine

Secondary outcomes

Other outcomes

Sponsors and contacts

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Ain Shams University

Lead sponsor

National Institute of Diabetes and Endocrinology, Egypt

Collaborator