Metabolic SyndromePhase 4NCT00314561
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
A Phase 4 study testing Pioglitazone, Rosiglitazone in people with Metabolic Syndrome, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pioglitazone, Rosiglitazone
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Renal dysfunction
- Heart failure (EF < 50%)
- Expected life expectancy of < 1 year
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Metabolic Syndrome
- Being tested
- Pioglitazone, Rosiglitazone
- Keywords
- Rosiglitazone, Pioglitazone, FMD, PWV, atherosclerosis
- Medical subject headings
- Metabolic Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone, RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startMay 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dong Sup Choi, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314561
- Sponsor's protocol ID
- KoreaUAnanmH
- Status last verified
- Sep 2008
- First submitted
- 12 Apr 2006
- Last updated
- 1 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00314561
- Acronym / sponsor ID
- KoreaUAnanmH
- Conditions
- Metabolic Syndrome
- Keywords
- Rosiglitazone, Pioglitazone, FMD, PWV, atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Dec 2006
- First posted
- 14 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone, Rosiglitazone | Drug | – |
Primary outcome
The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
1 secondary outcome
The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Sup Choi, MD, PhD principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone, Rosiglitazone in people with Metabolic Syndrome, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.