Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01589705
Status:
TERMINATED
Last Update Posted:
2012-07-31
First Post:
2012-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relation Between Uric Acid Level and Endothelial Dysfunction in Patients With Polycystic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}, {'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}], 'ancestors': [{'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'Patients recruitment and analysis were terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-29', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD)', 'timeFrame': '4 months', 'description': 'ADMA,FMD and uric acid measurements were performed to determine endothelial dysfunction in ADPKD patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uric acid', 'polycystic kidney disease'], 'conditions': ['Polycystic Kidney, Autosomal Dominant']}, 'referencesModule': {'references': [{'pmid': '23887359', 'type': 'DERIVED', 'citation': 'Kocyigit I, Yilmaz MI, Orscelik O, Sipahioglu MH, Unal A, Eroglu E, Kalay N, Tokgoz B, Axelsson J, Oymak O. Serum uric acid levels and endothelial dysfunction in patients with autosomal dominant polycystic kidney disease. Nephron Clin Pract. 2013;123(3-4):157-64. doi: 10.1159/000353730. Epub 2013 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.', 'detailedDescription': 'This is the first study to evaluate the relationship between uric acid and endothelial dysfunction in patients with early stage ADPKD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with early stage(preserved renal function) Autosomal dominant polycystic kidney disease (n = 91) from two academic medical center.We also excluded the patients with a previous diagnosis of hypertension, gout, diabetes, current use of oral antidiabetic medication, insulin, thiazide, allopurinol or uricosuric, or a fasting glucose level 126 mg/dl. In addition, the subjects with a history of smoking or current use of any anti-hypertensive medication and statins were excluded', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ADPKD patients with normal renal function,\n* Normotensive ADPKD patients\n\nExclusion Criteria:\n\n* Patients with impaired kidney function,\n* Atherosclerotic disorders,\n* Diagnosis of hypertension, gout, diabetes,\n* Using of insulin, thiazide, allopurinol or uricosuric drugs'}, 'identificationModule': {'nctId': 'NCT01589705', 'briefTitle': 'The Relation Between Uric Acid Level and Endothelial Dysfunction in Patients With Polycystic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Endothelial Dysfunction in Patients With Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': 'Erciyes 2011/273'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'polycystic kidney ,no hypertension', 'description': 'The study evaluated the association of serum uric acid levels with endothelial dysfunction in early ADPKD patients with normal renal function'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Medical School', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Bulent Tokgoz, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erciyes University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'TC Erciyes University Medical School', 'investigatorFullName': 'Ismail Kocyigit', 'investigatorAffiliation': 'TC Erciyes University'}}}}