Clinical trial NCT00639080: Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients
Official title: Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Dyslipidemia
Lead sponsor: Endocrine Research Society
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population are type 2 diabetes patients who attend St.Paul's Diabetes Teaching and Training Centre (DTTC) and Dr. Hugh Tildesley's private office in Vancouver, BC Canada.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Endocrine Research Society
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, University of British Columbia
name: Hugh Tildesley, MD
role: PRINCIPAL_INVESTIGATOR
References: