---
title: The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
nct_id: NCT00314561
overall_status: COMPLETED
phase: PHASE4
sponsor: Korea University Anam Hospital
study_type: INTERVENTIONAL
primary_condition: Metabolic Syndrome
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00314561.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00314561"
ct_last_update_post_date: 2011-07-01
last_seen_at: "2026-05-12T07:03:02.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00314561](https://clinicaltrials.gov/study/NCT00314561)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Korea University Anam Hospital
- **Conditions:** Metabolic Syndrome
- **Start Date:** 2006-05
- **Completion Date:** 2006-12
- **CT.gov Last Update:** 2011-07-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **Pioglitazone, Rosiglitazone** (DRUG)

## Primary Outcomes

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

## Secondary Outcomes

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

## Locations (1)

- Korea University Anam Hospital, Seoul, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.korea university anam hospital|seoul|seoul|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00314561.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00314561*  
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