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临床试验/NCT02704494
NCT02704494已完成早期 1 期

Resveratrol's Effects in Diabetic Nephropathy

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Resveratrol + Losartan

干预措施: Resveratrol (Drug)

Resveratrol

Experimental

Resveratrol + Losartan

干预措施: Losartan (Drug)

Placebo

Placebo Comparator

Placebo + Losartan

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mesbah Shams, MD

Associate professor of internal medicine and endocrinology

Shiraz University of Medical Sciences

研究点 (1)

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