Metabolic SyndromePhase 4NCT00364221
Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome
A Phase 4 study testing Rosiglitazone in people with Metabolic Syndrome and Insulin Resistance, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance
- What is being tested?
- Rosiglitazone
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Oct 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nondiabetic subjects with an NCEP/ATP III diagnosis of the metabolic syndrome
Who cannot join
- Statin Medications, liver disease, cardiovascular disease, heart failure, diabetes, chronic kidney disease,
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center General Clinical Research Center
Denver, Colorado, 80262
About this study
Official title: The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome
The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. The purpose of this study is to find out if the medication, rosiglitazone, influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons with the metabolic syndrome. This is an early step to see if a medication, such as rosiglitazone, will be beneficial in people who have the metabolic syndrome.
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Being tested
- Rosiglitazone
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startNov 2004
- Primary completionJul 2006
- Study completionOct 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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina L Aquilante, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364221
- Sponsor's protocol ID
- 04-0447
- Status last verified
- Nov 2012
- First submitted
- 14 Aug 2006
- Last updated
- 22 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00364221
- Acronym / sponsor ID
- 04-0447
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Aug 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.
The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. The purpose of this study is to find out if the medication, rosiglitazone, influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons with the metabolic syndrome. This is an early step to see if a medication, such as rosiglitazone, will be beneficial in people who have the metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nondiabetic subjects with an NCEP/ATP III diagnosis of the metabolic syndrome
Key exclusion criteria (1 listed)
- Statin Medications, liver disease, cardiovascular disease, heart failure, diabetes, chronic kidney disease,
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 |
|---|---|---|
| Rosiglitazone | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Nov 2012.
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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.
Christina L Aquilante, PharmD principal investigator
University of Colorado, Denver
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 Rosiglitazone in people with Metabolic Syndrome and Insulin Resistance, run by University of Colorado, Denver at 1 site in United States.
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 1 inclusion and 1 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 22 Nov 2012. 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 United States. 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.
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 22 Nov 2012.