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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00573950 |
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Date of registration:
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13/12/2007 |
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Primary sponsor: |
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Public title:
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Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness
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Scientific title:
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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) |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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48 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00573950 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Dong Kim |
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Address:
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Telephone:
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+82-2-920-6566 |
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Email:
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ctcan@kumc.or.kr |
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Affiliation:
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Name:
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Hee Young Kim, MD, PhD |
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Address:
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Telephone:
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+82-2-920-5767 |
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Email:
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lynsette@korea.ac.kr |
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Affiliation:
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Name:
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Sin Gon Kim, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korea University Anam Hospital |
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Key inclusion & exclusion criteria
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- 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
- Type 2 diabetes (at least 1 criteria below)
1. fasting blood glucose = 126 mg/dL
2. postprandial 2hour glucose = 200 mg/dL
3. random blood glucose = 200 mg/dL with typical diabetes symptoms
- Metabolic syndrome : Asian-Pacific ATP III guideline
1. Fasting blood glucose = 110 mg/dL, or previously diagnosed type 2 diabetes
2. systolic and/or diastolic blood pressure =130/85 mmHg, or treatment of
previously diagnosed hypertension
3. Triglyceride = 150 mg/dL, or Specific treatment for this lipid abnormality
4. HDL-cholesterol < 40 mg/dL for men and < 50 mg/dL for women, or Specific
treatment for this lipid abnormality
5. Waist circumference = 90 for men and = 80 for women
Exclusion Criteria:
- Hypertensive patients with the use of ACE inhibitor or ARB
- Hyperlipidemic patients with the use of statin or fenofibrate
- Hepatic dysfunction
- Chronic alcohol or drug abuse
- Renal dysfunction
- Heart failure
- Patients who takes hormone replace therapy or steroid containing drugs
- 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
- Patients who haves disease influencing the results of the study such as neurologic,
digestive and neoplastic disease
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Metabolic Syndrome X
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Intervention(s)
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Drug: cilostazol
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Drug: Placebo
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Primary Outcome(s)
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The effect on pulse wave velocity (PWV)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
[Time Frame: 8 weeks]
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Secondary ID(s)
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cilostaar
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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