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Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Primary Purpose

Diabetes Mellitus, Type 2, Metabolic Syndrome X

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cilostazol
Placebo
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring cilostazol, Type 2 Diabetes mellitus, Metabolic Syndrome, adipocytokines, arterial stiffness, Pulse wave velocity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Korea Univerisity Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cilostazol

Placebo

Arm Description

cilostazol group

placebo group

Outcomes

Primary Outcome Measures

The effect on pulse wave velocity (PWV)

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2007
Last Updated
December 13, 2007
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00573950
Brief Title
Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Metabolic Syndrome X
Keywords
cilostazol, Type 2 Diabetes mellitus, Metabolic Syndrome, adipocytokines, arterial stiffness, Pulse wave velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol
Arm Type
Experimental
Arm Description
cilostazol group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo group
Intervention Type
Drug
Intervention Name(s)
cilostazol
Other Intervention Name(s)
pletaal
Intervention Description
50 mg two times a day for 2 weeks and then 100mg two times a day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention 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
Primary Outcome Measure Information:
Title
The effect on pulse wave velocity (PWV)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Young Kim, MD, PhD
Phone
+82-2-920-5767
Email
lynsette@korea.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sin Gon Kim, MD, PhD
Phone
+82-2-920-5767
Email
k50367@korea.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sin Gon Kim, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea Univerisity Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Kim
Phone
+82-2-920-6566
Email
ctcan@kumc.or.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
23886346
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.
Results Reference
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Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

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