Simvastatin Reduces Adiponectin Levels and Insulin Sensitivity

An observational study of Hypercholesterolemia, run by Gachon University Gil Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients. Read more about this study

Who is it for?: Ages 25 to 75 years
Conditions the study is for: Hypercholesterolemia
How many people: Not given
Where: 1 siteSouth Korea
Study dates: Jan 2004to not given
Phase: Observational
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: overweight hypercholesterolemic patients

Who may be able to join

Low-density lipoprotein cholesterol levels more than 100 and body mass index more than 23.0

Who cannot join

Patients with overt liver disease
Chronic renal failure
Hypothyroidism, myopathy
Uncontrolled diabetes
Severe hypertension, stroke
Acute coronary events
Coronary revascularization within the preceding 3 months, or
Alcohol abuse.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Gil Medical Center, Gachon University
Incheon, 405760

Other trials in South Korea

About this study

Official title: Phase 4 Study of Simvastatin That Affects Insulin Sensitivity

We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients.

Conditions: Hypercholesterolemia
Keywords: Lipophilic statins, Insulin resistance, hypercholesterolemic patients
Medical subject headings: Hypercholesterolemia, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004?

First posted18 Oct 2007 (estimated)
Study startJan 2004

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: Observational
Observational model: Case-control
Time perspective: Prospective

IDs, dates and publications

ClinicalTrials.gov ID: NCT00546182
Sponsor's protocol ID: GMC-200405
Status last verified: Oct 2007
First submitted: 17 Oct 2007
Last updated: 18 Oct 2007
Results posted: No
Data monitoring committee: Yes

Publications

Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.
PubMed 10205010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Simvastatin That Affects Insulin Sensitivity
ClinicalTrials.gov ID: NCT00546182
Acronym / sponsor ID: GMC-200405
Conditions: Hypercholesterolemia
Keywords: Lipophilic statins, Insulin resistance, hypercholesterolemic patients
Study type: Observational
Recruitment status: Completed
Lead sponsor: Gachon University Gil Medical CenterUniversity, hospital or other
Study start: Jan 2004
First posted: 18 Oct 2007 (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.

We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients.

Study design

Observational model: Case-control
Time perspective: Prospective

Who may qualify

Ages: 25 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: overweight hypercholesterolemic patients

Key inclusion criteria (1 listed)

Low-density lipoprotein cholesterol levels more than 100 and body mass index more than 23.0

Key exclusion criteria (8 listed)

Patients with overt liver disease
Chronic renal failure
Hypothyroidism, myopathy
Uncontrolled diabetes
Severe hypertension, stroke

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients

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 18 Oct 2007.
Results publication: PubMed 10205010Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population

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.

Kwang K Koh, MD,PhD principal investigator

Gachon University Gil Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of 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 8 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 18 Oct 2007. 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.

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?

simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546182, 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 18 Oct 2007.