NCT00314561

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 1, 2011

Status Verified

September 1, 2008

First QC Date

April 12, 2006

Last Update Submit

June 30, 2011

Conditions

Metabolic Syndrome

Keywords

RosiglitazonePioglitazoneFMDPWVatherosclerosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Pioglitazone, RosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Metabolic SyndromeAtherosclerosis

Interventions

PioglitazoneRosiglitazone

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dong Sup Choi, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 14, 2006

Study Start

May 1, 2006

Study Completion

December 1, 2006

Last Updated

July 1, 2011

Record last verified: 2008-09

Locations

KR(1)