Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

NCT ID: NCT00573950

Last Updated: 2007-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Metabolic Syndrome X

Keywords

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cilostazol Type 2 Diabetes mellitus Metabolic Syndrome adipocytokines arterial stiffness Pulse wave velocity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cilostazol

cilostazol group

Group Type EXPERIMENTAL

cilostazol

Intervention Type DRUG

50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks

Placebo

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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cilostazol

50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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pletaal

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Korea University Anam Hospital

Principal Investigators

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Sin Gon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

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Korea Univerisity Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Young Kim, MD, PhD

Role: CONTACT

Phone: +82-2-920-5767

Email: [email protected]

Sin Gon Kim, MD, PhD

Role: CONTACT

Phone: +82-2-920-5767

Email: [email protected]

Facility Contacts

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Dong Kim

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23886346 (View on PubMed)

Other Identifiers

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cilostaar

Identifier Type: -

Identifier Source: org_study_id