Oxidative Stress in Children and Adolescents With Diabetic Nephropathy and the Role of Adjuvant Alpha-lipoic Acid as an Antioxidant
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Total antioxidant capacity and Malondialdehyde
研究概览
简要总结
Endothelial dysfunction in diabetes is a central event in the pathogenesis of different microangioapthic changes. Nephropathy in patients with type 1 diabetes is a severe microvascular complication.
详细描述
Better understanding of the pathogenesis of microvascular complications in type 1 diabetes have paved the way for novel therapeutic targets and possible adjuvant therapeutic modalities. Oxidative stress is considered a common and important factor that links hyperglycemia with the vascular complications in diabetes, including of diabetic nephropathy (DN).
Alpha lipoic acid (ALA), or thioctacid, is an antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes. ALA can scavenge free radicals, activate antioxidant systems, and also affect inflammatory markers. It also has unique characteristic. ALA can play as a reduction for oxidized forms of components with antioxidant properties and neutralize reactive oxygen species. Thus, it called as antioxidant of antioxidants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents with type 1 diabetes
- •The presence of diabetic nephropathy
排除标准
- •Renal impairment due to causes other than diabetes
- •Other diabetic complications than nephropathy
- •Elevated liver enzymes
- •Hypersensitivity to lipoic acid
- •Participation in a previous investigational drug study within the 30 days preceding screening
研究组 & 干预措施
Interventional arm
including pediatric patients with diabetic nephropathy receiving oral alpha-lipoic acid daily.
The capsule of ALA ( Thiotex 300 mg capsule) contains 300 mg of thioctic acid, manufactured bt Marcyrl Pharmaceutical Industries - Egypt.) The patient will receive 1 capsule twice daily for 3 months. Patients' compliance to therapy will be checked by counting pills.
oral angiotensin-converting enzyme inhibitors (ACE-Is) captopril 25 mg tablet provided their blood pressure will be maintained within normal range for age
干预措施: Thioctic Acid 333 MG Oral Capsule (Drug)
Interventional arm
including pediatric patients with diabetic nephropathy receiving oral alpha-lipoic acid daily.
The capsule of ALA ( Thiotex 300 mg capsule) contains 300 mg of thioctic acid, manufactured bt Marcyrl Pharmaceutical Industries - Egypt.) The patient will receive 1 capsule twice daily for 3 months. Patients' compliance to therapy will be checked by counting pills.
oral angiotensin-converting enzyme inhibitors (ACE-Is) captopril 25 mg tablet provided their blood pressure will be maintained within normal range for age
干预措施: Captopril 25Mg Tab (Drug)
Control Arm
including pediatric patients with diabetic nephropathy receiving placebo that is similar in appearance to the oral alpha-lipoic acid (Thiotex 300 mg capsule) and oral angiotensin-converting enzyme inhibitors (ACE-Is)(Captopril 25 mg tablet) provided their blood pressure will be maintained within normal range for age
干预措施: Captopril 25Mg Tab (Drug)
结局指标
主要结局
Changes in Total antioxidant capacity and Malondialdehyde
时间窗: 3 months
Changes in Total antioxidant capacity and Malondialdehyde
Changes in urinary albumin excretion rate
时间窗: 3 months
Changes in urinary albumin excretion rate and HbA1c
次要结局
未报告次要终点