Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-03-06 @ 3:26 PM
Study NCT ID:
NCT02384902
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2014-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-09', 'studyFirstSubmitDate': '2014-09-06', 'studyFirstSubmitQcDate': '2015-03-09', 'lastUpdatePostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fasting blood sugar (FBS) and lipid profile concentrations (mg/dl) were measured using commercially available enzymatic reagents adopted to an auto-analyzer system.', 'timeFrame': 'baseline, wk 12'}], 'primaryOutcomes': [{'measure': 'Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.', 'timeFrame': 'baseline, wk 12'}], 'secondaryOutcomes': [{'measure': 'Serum levels of high sensitive C- reactive protein (hs-CRP) (mg/L) were quantified by using an ultrasensitive latex-enhanced immunoturbidimetric assay (Randox Laboratory Ltd., Belfast, United Kingdom).', 'timeFrame': 'baseline, wk 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glycemic index', 'diabetic nephropathy', 'low glycemic load', 'inflammation'], 'conditions': ['Diabetic Nephropathy', 'Medication Compliance']}, 'descriptionModule': {'briefSummary': 'low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.\n\nlow GL may have more favorable effect than low GI diet.', 'detailedDescription': 'According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic nephropathy, medication stable\n\nExclusion Criteria:\n\n* poor adherence of dietary recommendations, any changes in kind or dosage of medications'}, 'identificationModule': {'nctId': 'NCT02384902', 'briefTitle': 'Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients', 'orgStudyIdInfo': {'id': 'low GI nephropathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low GI', 'description': 'low GI: participants were asked to consume low GI foods (GI\\<55) in abundant, medium GI in moderate and high GI (GI\\>70) rarely.', 'interventionNames': ['Other: low GI']}, {'type': 'EXPERIMENTAL', 'label': 'low GL', 'description': 'low GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled.', 'interventionNames': ['Other: low GI']}, {'type': 'EXPERIMENTAL', 'label': 'conventional diet', 'description': 'conventional diet: all carbohydrate were treated as the same.', 'interventionNames': ['Other: conventional diet']}], 'interventions': [{'name': 'low GI', 'type': 'OTHER', 'description': 'All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.', 'armGroupLabels': ['low GI']}, {'name': 'low GI', 'type': 'OTHER', 'description': 'All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.', 'armGroupLabels': ['low GL']}, {'name': 'conventional diet', 'type': 'OTHER', 'description': 'All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.', 'armGroupLabels': ['conventional diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Leila Azadbakht', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'leila azadbakht, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Leila Azadbakht', 'investigatorFullName': 'Leila Azadbakht', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}