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临床试验/NCT01419912
NCT01419912已完成3 期

Comparison of Soy-milk and Cow Milk Consumption on Inflammatory Factors, Cardiovascular Factors ,Renal Factors, Fibrinolytic Indice and Oxidative Stress Among Type-2 Diabetic Patients With Nephropathy Stage 1 and 2

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家开始时间: 2011年8月18日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
试验地点
1
主要终点
soy milk

研究概览

简要总结

Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with DN and there are few data about relationship of soy milk consumption and health effect in patients with DN . Therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.

研究设计

研究类型
Interventional
干预模型
Crossover

入排标准

年龄范围
28 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults with (>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min )

排除标准

  • exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women
  • changing dosage of oral hypoglycemic agents
  • insulin therapy
  • lipid-lowering medications
  • use of hormone replacement therapy
  • alcohol and cigarette consumption;allergy or intolerance to soybeans or milk
  • presence of breast malignant and avoid of advisory diet

结局指标

主要结局

soy milk

次要结局

  • HbA1c
  • creatinin
  • total cholesterol
  • insulin
  • systolic blood pressure
  • diastolic blood pressure
  • Malondialdehyde
  • fibrinogen
  • Urine creatinine
  • urine protein
  • BUN
  • TNF-α
  • IL6
  • FBS
  • TG
  • hs-CRP
  • d-dimer
  • HDL
  • LDL

研究者

申办方类型
Other

研究点 (1)

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