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The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pioglitazone, Rosiglitazone
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Rosiglitazone, Pioglitazone, FMD, PWV, atherosclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol < 40 mg/dl for men and < 50 mg/dl for women. Age: 18 years and above Exclusion Criteria: Hypertensive patients with the use of ACE inhibitor or ARB Hyperlipidemic patients with the use of statin or fenofibrate Patients with any contraindications to the treatment of thiazolidinediones Pregnant or lactating patients Chronic alcohol or drug abuse Hepatic dysfunction Renal dysfunction Heart failure (EF < 50%) Expected life expectancy of < 1 year

Sites / Locations

  • Korea University Anam Hospital

Outcomes

Primary Outcome Measures

The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)

Secondary Outcome Measures

The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.

Full Information

First Posted
April 12, 2006
Last Updated
June 30, 2011
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00314561
Brief Title
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
Official Title
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome: A Prospective, Randomized, Open-label, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University Anam Hospital

4. Oversight

5. Study Description

Brief Summary
Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Rosiglitazone, Pioglitazone, FMD, PWV, atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pioglitazone, Rosiglitazone
Primary Outcome Measure Information:
Title
The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
Secondary Outcome Measure Information:
Title
The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol < 40 mg/dl for men and < 50 mg/dl for women. Age: 18 years and above Exclusion Criteria: Hypertensive patients with the use of ACE inhibitor or ARB Hyperlipidemic patients with the use of statin or fenofibrate Patients with any contraindications to the treatment of thiazolidinediones Pregnant or lactating patients Chronic alcohol or drug abuse Hepatic dysfunction Renal dysfunction Heart failure (EF < 50%) Expected life expectancy of < 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Sup Choi, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome

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