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Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

NCT00639080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2011-07-22

No results posted yet for this study

Summary

Purpose:

To assess prior need for lipid lowering therapy in patients with type 2 diabetes.

Background/Hypothesis:

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.

Objectives:

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Endocrine Research Society

    lead OTHER

Principal Investigators

  • Hugh Tildesley, MD · St. Paul's Hospital, University of British Columbia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639080 on ClinicalTrials.gov