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

Study Overview
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Brief Summary
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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.

Conditions
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Inflammation, Oxidative Stress, Fibrinolytic Markers, Blood Pressure and Cardiorenal Risk Factors

Intervention / Treatment
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* Dietary Supplement: soy milk
* Dietary Supplement: cow's milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soy milk<br> | Dietary Supplement: soy milk<br> <br> |
| Experimental: cow's milk<br> | Dietary Supplement: cow's milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| soy milk |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |