Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

Type 2 Diabetes Clinical Trial

Official title:

Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639080
• Other study ID #: Necessity for LLT
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: July 21, 2011
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2009
• Source: Endocrine Research Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• LDL < 2.5 mmol/L and total cholesterol: HDL-cholesterol ratio < 4.0

• Blood pressure = 130/80 mmHg

• No personal or family history of CVD

• No history of proteinuria or renal failure

• Taking atorvastatin (lipitor) with a dosage = 10 mg, equivalent dosages for other statins follow this requirement (Simvastatin = 20 mg, pravastatin = 40 mg, rosuvastatin = 5 mg, fluvastatin = 40 mg and lovastatin = 40 mg)

• Calculated by the UKPDS Risk Engine to be low risk (risk is less than 15%) for Coronary Heart Disease (CHD), fatal CHD, stroke and fatal stroke (the UKPDS Risk Engine provides risk estimates in individuals with type 2 diabetes not known to have heart disease (1), calculating the patient's risk involves considering risk factors such as age, sex, incidence of smoking and lipid levels)

Exclusion Criteria:

• Patients who do not meet the above criteria or are not willing to participate will not be included in the study

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	Endocrine Research Society	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Endocrine Research Society

Country where clinical trial is conducted

Canada,