A Comparative Clinical Study to Evaluate the Efficacy of Melatonin in the Treatment of Diabetic Nephropathy Compared With Folic Acid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in the urine albumin-to-creatinine ratio (UACR)
研究概览
简要总结
The current study aims to investigate and compare the anti-inflammatory effects of melatonin versus folic acid in patients with diabetic nephropathy.
详细描述
Diabetes mellitus (DM) is a metabolic disorder characterized by chronic hyperglycemia, resulting from either insufficient insulin production (Type I) or ineffective insulin utilization (Type II).
Melatonin, a hormone produced by the pineal gland, regulates circadian rhythms and exhibits strong antioxidant, anti-inflammatory, and immunomodulatory properties.
Folic acid, a B-vitamin essential for cell division and DNA synthesis, also exerts antioxidant effects and supports endothelial function by lowering plasma homocysteine levels.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-75 years.
- •Patients with a confirmed diagnosis of Type 2 diabetes and diabetic nephropathy, as indicated by an elevated urine albumin-to-creatinine ratio (UACR ≥ 30 mg/g) or a decreased estimated glomerular filtration rate (eGFR < 60 mL/min/1.73 m²).
排除标准
- •Patients who are expectant or breastfeeding.
- •Have significant comorbidities.
- •Have rapidly declining renal function.
- •Have acute kidney injury.
研究组 & 干预措施
Group 1
Patients in the control group will receive conventional diabetic treatment.
干预措施: Conventional diabetic treatment (Drug)
Group 2
Patients who received receive normal therapy augmented with folic acid (400 µg/day).
干预措施: Folic acid (Drug)
Group 3
Patients who receive standard therapy supplemented with melatonin (3 mg/day).
干预措施: Melatonin (Drug)
结局指标
主要结局
Change in the urine albumin-to-creatinine ratio (UACR)
时间窗: 12-week after treatment
Change in the urine albumin-to-creatinine ratio (UACR) will be recorded. The UACR is an important biomarker of kidney impairment because it measures the quantity of albumin discharged in the urine in relation to creatinine levels. Elevated UACR readings (≥ 30 mg/g) indicate albuminuria, a symptom of diabetic nephropathy.
次要结局
- Change in the estimated glomerular filtration rate (eGFR)(12-week after treatment)
- Change in the serum creatinine(12-week after treatment)
- Change in the neutrophil gelatinase-associated lipocalin (NGAL)(12-week after treatment)
研究者
Mohammed Ghodaer Alshamri
MSc in Pharmacy (Clinical Pharmacy), Faculty of Pharmacy, Tanta University, Egypt
Tanta University