Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

December 13, 2007 updated by: Korea University Anam Hospital

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo group
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
Experimental: Cilostazol
cilostazol group
Drug: cilostazol
50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
Other Names:
  • pletaal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect on pulse wave velocity (PWV)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Investigators

  • Principal Investigator: Sin Gon Kim, MD, PhD, Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

December 14, 2007

Last Update Submitted That Met QC Criteria

December 13, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cilostaar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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