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Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

⁃ HbA1C (glycosylated hemoglobin) less than 10%

⁃ FBG less than 240 mg/dl

⁃ Body mass index (BMI) less than 40 kg/m2

Locations
Other Locations
Egypt
National Institute of Diabetes and Endocrinology.
RECRUITING
Cairo
National Institute of Diabetes and Endocrinology.
RECRUITING
Cairo
Contact Information
Primary
Nelly tarek Hegazy
nelly.tariq@pharma.asu.edu.eg
01010008548
Backup
Lamiaa Elwakeel, Professor
Time Frame
Start Date: 2026-01-10
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 76
Treatments
No_intervention: NPDR patients will receive placebo for three months.
The patients will receive placebo for three months. In addition to the standard of care antidiabetic management.
Experimental: NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.
NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.
Sponsors
Leads: Ain Shams University
Collaborators: National Institute of Diabetes and Endocrinology, Egypt

This content was sourced from clinicaltrials.gov