Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-16 @ 3:05 PM
Study NCT ID:
NCT00573950
Status:
UNKNOWN
Last Update Posted:
2007-12-14
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-05-11', 'releaseDate': '2011-04-18'}], 'estimatedResultsFirstSubmitDate': '2011-04-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-13', 'studyFirstSubmitDate': '2007-12-13', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect on pulse wave velocity (PWV)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cilostazol', 'Type 2 Diabetes mellitus', 'Metabolic Syndrome', 'adipocytokines', 'arterial stiffness', 'Pulse wave velocity'], 'conditions': ['Diabetes Mellitus, Type 2', 'Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '23886346', 'type': 'DERIVED', 'citation': 'Kim NH, Kim HY, An H, Seo JA, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. Effect of cilostazol on arterial stiffness and vascular adhesion molecules in type 2 diabetic patients with metabolic syndrome: a randomised, double-blind, placebo-controlled, crossover trial. Diabetol Metab Syndr. 2013 Jul 26;5(1):41. doi: 10.1186/1758-5996-5-41.'}]}, 'descriptionModule': {'briefSummary': 'Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few clinical studies that support these effects of cilostazol. The purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and plasma adipocytokines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Eligible for study: 18 year and above, Gender eligible for study: both Inclusion Criteria:Type 2 diabetes patients with metabolic syndrome criteria of Asian-Pacific ATP III guideline\n* Type 2 diabetes (at least 1 criteria below)\n\n 1. fasting blood glucose ≥ 126 mg/dL\n 2. postprandial 2hour glucose ≥ 200 mg/dL\n 3. random blood glucose ≥ 200 mg/dL with typical diabetes symptoms\n* Metabolic syndrome : Asian-Pacific ATP III guideline\n\n 1. Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes\n 2. systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension\n 3. Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality\n 4. HDL-cholesterol \\< 40 mg/dL for men and \\< 50 mg/dL for women, or Specific treatment for this lipid abnormality\n 5. Waist circumference ≥ 90 for men and ≥ 80 for women\n\nExclusion Criteria:\n\n* Hypertensive patients with the use of ACE inhibitor or ARB\n* Hyperlipidemic patients with the use of statin or fenofibrate\n* Hepatic dysfunction\n* Chronic alcohol or drug abuse\n* Renal dysfunction\n* Heart failure\n* Patients who takes hormone replace therapy or steroid containing drugs\n* Patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine E1 , drugs inhibit CYP3A4 or CYP2C19, or drugs become substrate of CYP3A4\n* Patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease'}, 'identificationModule': {'nctId': 'NCT00573950', 'briefTitle': 'Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness in Type 2 Diabetes Patient With Metabolic Syndrome (Randomized, Double-Blind, Placebo-Controled, Cross-Over Study)', 'orgStudyIdInfo': {'id': 'cilostaar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cilostazol', 'description': 'cilostazol group', 'interventionNames': ['Drug: cilostazol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'cilostazol', 'type': 'DRUG', 'otherNames': ['pletaal'], 'description': '50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks', 'armGroupLabels': ['Cilostazol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet comparable to 50mg cilostazol two times a day for 2 weeks and then placebo tablet comparable to 100mg cilostazol two times a day for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong Kim', 'role': 'CONTACT', 'email': 'ctcan@kumc.or.kr', 'phone': '+82-2-920-6566'}], 'facility': 'Korea Univerisity Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hee Young Kim, MD, PhD', 'role': 'CONTACT', 'email': 'lynsette@korea.ac.kr', 'phone': '+82-2-920-5767'}, {'name': 'Sin Gon Kim, MD, PhD', 'role': 'CONTACT', 'email': 'k50367@korea.ac.kr', 'phone': '+82-2-920-5767'}], 'overallOfficials': [{'name': 'Sin Gon Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sin Gon, Kim', 'oldOrganization': 'Korea University Anam Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-04-18', 'type': 'RELEASE'}, {'date': '2011-05-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sin Gon Kim, Professor, Korea University Anam Hospital'}}}}