HypercholesterolemiaPhase 4NCT00745836
Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients
A Phase 4 study testing statin in people with Hypercholesterolemia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
High dose atorvastatin may worsen insulin sensitivity. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2005to Aug 2008
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypercholesterolemia
Who cannot join
- chronic renal disease
Trial locations and contacts
1 site in 1 country.
About this study
High dose atorvastatin may worsen insulin sensitivity.
- Conditions
- Hypercholesterolemia
- Being tested
- statin
- Keywords
- insulin sensitivity
- Medical subject headings
- Hypercholesterolemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statinDrug
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin 10 mg, 80 mg | Experimental | Not described Receives: Drug: statin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJan 2005
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745836
- Sponsor's protocol ID
- GMC-200508
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2008
- Last updated
- 3 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koh KK, Quon MJ, Han SH, Lee Y, Kim SJ, Shin EK. Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol. 2010 Mar 23;55(12):1209-1216. doi: 10.1016/j.jacc.2009.10.053.
PubMed 20298928
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients
- ClinicalTrials.gov ID
- NCT00745836
- Acronym / sponsor ID
- GMC-200508
- Conditions
- Hypercholesterolemia
- Keywords
- insulin sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Sep 2008 (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.
High dose atorvastatin may worsen insulin sensitivity.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atorvastatin 10 mg, 80 mg | Experimental | Drug: statin |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hypercholesterolemia
Key exclusion criteria (1 listed)
- chronic renal 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 |
|---|---|---|
| statin | Drug | atorvastatin 10 mg, 80 mg |
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 3 Sep 2008.
- Derived from this study: PubMed 20298928Koh KK, Quon MJ, Han SH, Lee Y, Kim SJ, Shin EK. Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol. 2010 Mar 23;55(12):1209-1216. doi: 10.1016/j.jacc.2009.10.053.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 statin in people with Hypercholesterolemia, run by Gachon University Gil Medical Center 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 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 3 Sep 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745836, which also lists 1 linked publication.
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 3 Sep 2008.