Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients
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|ClinicalTrials.gov Identifier: NCT00639080|
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : July 22, 2011
To assess prior need for lipid lowering therapy in patients with type 2 diabetes.
At present, lipid lowering therapy, usually with a HMG-CoA reductase inhibitor or "statin", is recommended therapy for selected patients with type 2 diabetes mellitus (DM). The use of statins for primary prevention of CVD is not clear. Some primary prevention studies have found a statistically significant benefit but others have not (CARDS and ASPEN).
Although low-density lipoprotein (LDL) has traditionally been a key marker of cardiovascular disease risk (CVD) risk and thus a guide to statin treatment, in recent years apolipoprotein B (apoB) has emerged as an independent risk factor for CVD.
In a recent study, Tildesley H. et al. showed that in 500 patients with type 2 DM not on lipid lowering therapy there was discordance between LDL and apoB values. Specifically, it was found that among patients who fail to achieve the LDL-C target, 13% of men, 24% of women less than 50 and 13% of women greater than 50 meet the apoB target. In other words, while the LDL level would indicate treatment, the apoB level would not.
The investigators propose to measure lipid parameters during lipid lowering therapy and compare this with lipid parameters at one and two months after discontinuation of therapy in selected patients with type 2 DM at low risk for CVD. Lipid parameters to be measured include: high-density lipoprotein (HDL) - cholesterol, LDL-cholesterol, triglycerides, total cholesterol, total cholesterol: HDL-cholesterol ratio and apoB. As well, A1C will be measured.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes||Other: Stop lipid lowering therapy (statin)|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Observational Model:||Case Control|
|Official Title:||Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Entire study population
All study subjects.
Other: Stop lipid lowering therapy (statin)
Subjects will only be included in the study and thus asked to stop the statin if they are taking less than or equal to 10 mg of lipitor or an equivalent of another statin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639080
|Canada, British Columbia|
|Endocrine Research Society|
|Vancouver, British Columbia, Canada, V6E 1M7|
|Principal Investigator:||Hugh Tildesley, MD||St. Paul's Hospital, University of British Columbia|