Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Eligible patients will be randomly assigned into one of two groups. In the first group : patients will receive N-acetyl cysteine 1200 mg once daily for three months.
In addition to the standard of care antidiabetic management. In the second group: patients will take matched placebo for three months. In addition to the standard of care antidiabetic management.
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Demographic data collection and history taking:
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Age
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Gender
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BMI
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Smoking status
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Diabetes duration
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Family history
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Medical history: Hypertension, Dyslipidemia, etc.
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Medications history especially those related to the occurrence of retinopathy
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Clinical assessment, scoring & investigations:
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Systolic and diastolic blood pressures.
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Stage of retinopathy
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Ophthalmologic examination:
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Clinical examination to assess:Visual acuity and Field of vision
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Laboratory assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• Patients with any other ophthalmologic conditions than diabetic retinopathy
- •Patients with previous surgical or laser treatment
- •Pregnant or breastfeeding patients
- •Patients using antioxidants.
- •Systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization
- •Patients who are currently participating in other clinical trials
- •Severe liver or renal disease, (AST or ALT >3 times ULN or Total bilirubin >3 times ULN), (CrCl< 60 ml/min)
- •Current history of drug or alcohol abuse Malignancies
研究者
Nelly Hegazy
Principle Investigator
Ain Shams University