Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02704494
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resveratrol's Effects in Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D000419', 'term': 'Albuminuria'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-03-06', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine albumin level', 'timeFrame': '3 months'}, {'measure': 'Serum creatinin', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Fasting blood sugar (FBS)', 'timeFrame': '3 months'}, {'measure': 'Glycosylated hemoglobin (A1C)', 'timeFrame': '3 months'}, {'measure': 'Liver aminotransferases (ALT and AST)', 'timeFrame': '3 months'}, {'measure': 'Serum insulin level', 'timeFrame': '3 months'}, {'measure': 'Number of patients with adverse events', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Resveratrol', 'Diabetes mellitus', 'Diabetes complications', 'Diabetic nephropathies', 'Proteinuria', 'Albuminuria', 'renal insufficiency'], 'conditions': ['Diabetic Nephropathy']}, 'referencesModule': {'references': [{'pmid': '37916745', 'type': 'DERIVED', 'citation': 'Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.'}, {'pmid': '29983230', 'type': 'DERIVED', 'citation': 'Sattarinezhad A, Roozbeh J, Shirazi Yeganeh B, Omrani GR, Shams M. Resveratrol reduces albuminuria in diabetic nephropathy: A randomized double-blind placebo-controlled clinical trial. Diabetes Metab. 2019 Jan;45(1):53-59. doi: 10.1016/j.diabet.2018.05.010. Epub 2018 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.', 'detailedDescription': "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.\n\nResveratrol (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.\n\nResveratrol 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.\n\nWe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (DM)\n* Controlled blood sugar \\[fasting blood sugar (FBS) \\<130mg/dl and glycosylated hemoglobin (A1C)\\<7%\n* Urine albumin \\>20mg/lit in two separate occasions during the last 3 months period\n* Serum creatinin \\< or = 2mg/dl\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Alcoholism\n* Liver failure (acute or chronic)\n* Renal failure: serum creatinin \\>2mg/dl\n* Glomerulonephritis\n* Uncontrolled hypertension\n* Congestive heart failure\n* Prostate disease\n* Malignancy\n* Bilateral renal artery stenosis\n* Any systemic disease other than DM\n* Any infection or rheumatologic disorder\n* Use of warfarin'}, 'identificationModule': {'nctId': 'NCT02704494', 'acronym': 'ReDNeph', 'briefTitle': "Resveratrol's Effects in Diabetic Nephropathy", 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': "Resveratrol's Effects in Diabetic Nephropathy", 'orgStudyIdInfo': {'id': '93-01-49-9028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resveratrol', 'description': 'Resveratrol + Losartan', 'interventionNames': ['Drug: Resveratrol', 'Drug: Losartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + Losartan', 'interventionNames': ['Drug: Placebo', 'Drug: Losartan']}], 'interventions': [{'name': 'Resveratrol', 'type': 'DRUG', 'description': 'Resveratrol 500mg daily', 'armGroupLabels': ['Resveratrol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 1 capsule daily', 'armGroupLabels': ['Placebo']}, {'name': 'Losartan', 'type': 'DRUG', 'description': 'Losartan 12.5mg daily', 'armGroupLabels': ['Placebo', 'Resveratrol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shahid Motahhari Clinic, Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Gholamhossein Ranjbar Omrani, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences'}, {'name': 'Jamshid Roozbeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences'}, {'name': 'Azar Sattarinejad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences'}, {'name': 'Mesbah Shams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of internal medicine and endocrinology', 'investigatorFullName': 'Mesbah Shams, MD', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}