Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01419912
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2011-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041942', 'term': 'Soy Milk'}, {'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D003611', 'term': 'Dairy Products'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2011-08-17', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'soy milk'}], 'secondaryOutcomes': [{'measure': 'HbA1c'}, {'measure': 'creatinin'}, {'measure': 'total cholesterol'}, {'measure': 'insulin'}, {'measure': 'systolic blood pressure'}, {'measure': 'diastolic blood pressure'}, {'measure': 'Malondialdehyde'}, {'measure': 'fibrinogen'}, {'measure': 'Urine creatinine'}, {'measure': 'urine protein'}, {'measure': 'BUN'}, {'measure': 'TNF-α'}, {'measure': 'IL6'}, {'measure': 'FBS'}, {'measure': 'TG'}, {'measure': 'hs-CRP'}, {'measure': 'd-dimer'}, {'measure': 'HDL'}, {'measure': 'LDL'}]}, 'conditionsModule': {'conditions': ['Inflammation', 'Oxidative Stress', 'Fibrinolytic Markers', 'Blood Pressure and Cardiorenal Risk Factors']}, 'referencesModule': {'references': [{'pmid': '22787172', 'type': 'DERIVED', 'citation': 'Miraghajani MS, Esmaillzadeh A, Najafabadi MM, Mirlohi M, Azadbakht L. Soy milk consumption, inflammation, coagulation, and oxidative stress among type 2 diabetic patients with nephropathy. Diabetes Care. 2012 Oct;35(10):1981-5. doi: 10.2337/dc12-0250. Epub 2012 Jul 11.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '28 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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 )\n\nExclusion Criteria:\n\n* exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women\n* changing dosage of oral hypoglycemic agents\n* insulin therapy\n* lipid-lowering medications\n* use of hormone replacement therapy\n* alcohol and cigarette consumption;allergy or intolerance to soybeans or milk\n* presence of breast malignant and avoid of advisory diet'}, 'identificationModule': {'nctId': 'NCT01419912', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'soymilk and nephropathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'soy milk', 'interventionNames': ['Dietary Supplement: soy milk']}, {'type': 'EXPERIMENTAL', 'label': "cow's milk", 'interventionNames': ["Dietary Supplement: cow's milk"]}], 'interventions': [{'name': 'soy milk', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['soy milk']}, {'name': "cow's milk", 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ["cow's milk"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'country': 'Iran', 'facility': 'Isfahan University of Medical Sciences', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}}}}