Resveratrol's Effects in Diabetic Nephropathy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum creatinin
研究概览
简要总结
The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
详细描述
Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. One of the most important complications of DM is nephropathy.
Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. The richest natural source of resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine.
Resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals.
We hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (DM)
- •Controlled blood sugar [fasting blood sugar (FBS) <130mg/dl and glycosylated hemoglobin (A1C)<7%
- •Urine albumin >20mg/lit in two separate occasions during the last 3 months period
- •Serum creatinin < or = 2mg/dl
排除标准
- •Pregnancy
- •Lactation
- •Alcoholism
- •Liver failure (acute or chronic)
- •Renal failure: serum creatinin >2mg/dl
- •Glomerulonephritis
- •Uncontrolled hypertension
- •Congestive heart failure
- •Prostate disease
- •Malignancy
- •Bilateral renal artery stenosis
- •Any systemic disease other than DM
- •Any infection or rheumatologic disorder
- •Use of warfarin
研究组 & 干预措施
Resveratrol
Resveratrol + Losartan
干预措施: Resveratrol (Drug)
Resveratrol
Resveratrol + Losartan
干预措施: Losartan (Drug)
Placebo
Placebo + Losartan
干预措施: Placebo (Drug)
Placebo
Placebo + Losartan
干预措施: Losartan (Drug)
结局指标
主要结局
Serum creatinin
时间窗: 3 months
Urine albumin level
时间窗: 3 months
次要结局
- Liver aminotransferases (ALT and AST)(3 months)
- Fasting blood sugar (FBS)(3 months)
- Glycosylated hemoglobin (A1C)(3 months)
- Serum insulin level(3 months)
- Number of patients with adverse events(3 months)
研究者
Mesbah Shams, MD
Associate professor of internal medicine and endocrinology
Shiraz University of Medical Sciences
