Clinical trial NCT00573950: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Metabolic Syndrome X
Keywords: cilostazol
Type 2 Diabetes mellitus
Metabolic Syndrome
adipocytokines
arterial stiffness
Pulse wave velocity
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

  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

Primary outcomes:
measure: The effect on pulse wave velocity (PWV)
timeFrame: 8 weeks
Secondary outcomes:
measure: the effect on atherosclerotic and inflammatory markers such as adiponectin, hsCRP
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Univerisity Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Sin Gon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.