Effect of Oral Supplementation With Curcumin in Patients With Proteinuric Diabetic Kidney Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Urine protein excretion
研究概览
简要总结
The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria, improves the redox and pro-inflammatory state in patients with chronic kidney disease associated to Diabetes mellitus.
详细描述
Diabetic Kidney Disease (DKD) represents the fist cause of end-stage kidney disease in Mexico and the world, and it is characterized by the presence of hyperfiltration, glomerular hypertrophy, tubular albuminuria and mesangial matrix expansion, mainly by the oxidative stress and the pro-inflammatory state.
Current treatments are limited on controlling proteinuria and delay progression of the disease, but even with an optimal management, a significant number of patient progress to end-stage renal disease.
Curcumin, found in the extracts of the rhizome of the plant Curcuma longa L., has a wide spectrum of biological and pharmacological activities, such as anti-oxidant, anti-inflammatory, anti-carcinogenic and anti-diabetic effects. It has the capacity to act directly with highly reactive oxygen species, induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway and reducing inflammatory transcription factors such as NF-κB and TNF-α.
Curcumin could be an adjuvant treatment in the management of DKC due to his pleiotropic nature, low cost and few side effects.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Diabetes Mellitus type 2 and proteinuric kidney disease with 1000 mg of more proteins in daily recollection
- •Glomerular filtration rate between 15-60 mL/min/ 1.73 m2 calculated by CKD-EPI
- •Patients taking Angiotensin II Receptor Blocker or ACE inhibitors
排除标准
- •Renal replacement therapy
- •Autoimmune disease or malignancy
- •Pregnancy
- •Hepatic damage
- •Congestive heart failure classification III or IV (NYHA)
- •History of organ transplantation
- •History of chemotherapy or immunosuppression within 2 years prior to screening
结局指标
主要结局
Urine protein excretion
时间窗: 24 weeks
Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).
次要结局
- Malondialdehyde (MDA)(6 months)
- Proinflammatory status(6 months)
- Free radical scavenging activity(6 months)
研究者
Magdalena Madero
MD, Chief of the Nephrology Department
Instituto Nacional de Cardiologia Ignacio Chavez