Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
研究概览
简要总结
The aim of the current study is to evaluate the efficacy and safety of high dose oral NAC (2400 mg/day divided into two doses) as an adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in patients with type 2 diabetes suffering from diabetic peripheral neuropathy.
详细描述
Patient written informed consent will be taken prior to study conductance
- Lab assessment will be done at baseline and at the end of the study by withdrawing 7 ml of whole blood for assessment of following parameters: HbA1c, Liver & renal functions
- Inflammatory markers including: Human Nuclear factor erythroid 2-related factor (NRF2) & Tumor necrosis factor alpha (TNF-α) using ELISA Kit
- Oxidative stress markers: Glutathione Peroxidase using ELISA Kit
Inflammatory and oxidative stress marker samples will be stored at -80 for further evaluation using ELISA kit at the end of the study
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)
- •Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature probe, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).
排除标准
- •Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.
- •Pregnancy or lactation or expecting to get pregnant during the study.
- •Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
- •Cancer patients.
- •Anyone having hypersensitivity to N-acetylcysteine.
- •Anyone already taking N-acetylcysteine.
研究组 & 干预措施
Group 1, NAC group
Group 1, NAC group (n=30): Patients will receive conventional therapy for diabetic neuropathy in addition to High Dose N-acetyl cysteine (2400 mg/day divided into two doses) daily for 3 months
干预措施: Acetyl cysteine (Drug)
结局指标
主要结局
Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
时间窗: change from baseline Human Nuclear factor erythroid 2-related factor at 3 months
Inflammatory marker
Concentration of Tumor necrosis factor alpha
时间窗: Change from baseline tumor necrosis factor alpha at 3 months
Inflammatory marker
Concentration of Glutathione peroxidase
时间窗: Change from baseline glutathione peroxidase at 3 months
Oxidative stress markers
次要结局
未报告次要终点
研究者
Sherien Emara
Teaching Assistant
Ain Shams University