NCT00573950

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 14, 2007

Status Verified

December 1, 2007

First QC Date

December 13, 2007

Last Update Submit

December 13, 2007

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome X

Keywords

cilostazolType 2 Diabetes mellitusMetabolic Syndromeadipocytokinesarterial stiffnessPulse wave velocity

Outcome Measures

Primary Outcomes (1)

  • The effect on pulse wave velocity (PWV)

    8 weeks

Secondary Outcomes (1)

  • the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP

    8 weeks

Study Arms (2)

Cilostazol

EXPERIMENTAL

cilostazol group

Drug: cilostazol

Placebo

PLACEBO COMPARATOR

placebo group

Drug: Placebo

Interventions

cilostazolDRUG

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

Also known as: pletaal
Cilostazol
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes (at least 1 criteria below)
  • fasting blood glucose ≥ 126 mg/dL
  • postprandial 2hour glucose ≥ 200 mg/dL
  • random blood glucose ≥ 200 mg/dL with typical diabetes symptoms
  • Metabolic syndrome : Asian-Pacific ATP III guideline
  • Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes
  • systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension
  • Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality
  • HDL-cholesterol \< 40 mg/dL for men and \< 50 mg/dL for women, or Specific treatment for this lipid abnormality
  • Waist circumference ≥ 90 for men and ≥ 80 for women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea Univerisity Anam Hospital

Seoul, 136-705, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23886346DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sin Gon Kim, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Young Kim, MD, PhD

CONTACT

+82-2-920-5767lynsette@korea.ac.kr

Sin Gon Kim, MD, PhD

CONTACT

+82-2-920-5767k50367@korea.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

December 1, 2007

Study Completion

December 1, 2008

Last Updated

December 14, 2007

Record last verified: 2007-12

Locations

KR(1)