Possible Ameliorating Effect of N- Acetylcysteine on Type-II Diabetes Induced Nephropathy
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lipoprotein (a)
研究概览
简要总结
The study is focused on the possible improving effect of N-acetylcysteine on nephropathy of type-2 diabetic patients.
Study design: Prospective clinical based study. The aim of this work is to study the effect of N-acetylcysteine (NAC) on proteinuria and on the serum level of lipoprotein a (LPa) in diabetes induced nephropathy in type-2 diabetic patients.
详细描述
This study will be carried on 60 participants with Type 2 Diabetes with age over 20 years.
Participants will be classified into two groups:
- Group I (Interventional): treated with (NAC) dose of 1200 mg/day for two months in conjunction with conventional treatment.
- Group II (Non-interventional): control group receive conventional treatment.
All patients will undergo the following:
- Full medical history will be taken.
- Laboratory investigations as follows:
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
- None
盲法说明
All participants,investigators, care providers, and outcome assessor have knowledge of the interventions assigned to individual participants.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of Diabetes Mellitus.
- •Age over 20 years.
- •Patients with proteinuria ≥ 30 mg /dl.
排除标准
- •Patients on lipid lowering medications.
- •Cigarette smokers.
- •Presence of liver and heart diseases.
研究组 & 干预措施
Interventional
First arm is experimental, given (NAC) for 2 months in 1200mg/day dosing.
Both arms are assigned to pre-treatment analytical tests and post treatment all test analysis are repeated to compare drug effect with placebo group.
干预措施: N Acetylcysteine (Drug)
结局指标
主要结局
Lipoprotein (a)
时间窗: 2 months
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
Systolic blood pressure
时间窗: 2 months
The first number of blood pressure reading and it indicates how much pressure our blood is exerting against our artery walls when the heart beats. It is a major risk factor for cardiovascular disease.
Triglycerides
时间窗: 2 months
Triglycerides are a type of fat (lipid) found in our blood. It is one of the lipid panel used to determine atherosclerotic risk that contributes to vascular diseases.
次要结局
未报告次要终点
研究者
Tasneem Ahmed Hamed
Clinical pharamacist
Al-Azhar University