Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by:
Endocrine Research Society
ClinicalTrials.gov Identifier:
NCT00639080
First received: March 12, 2008
Last updated: July 21, 2011
Last verified: August 2009
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Other: Stop lipid lowering therapy (statin)

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Endocrine Research Society:

Enrollment: 25
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639080

Locations
Canada, British Columbia
Endocrine Research Society
Vancouver, British Columbia, Canada, V6E 1M7
Sponsors and Collaborators
Endocrine Research Society
Investigators
Principal Investigator: Hugh Tildesley, MD St. Paul's Hospital, University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Hugh Tildesley, Endocrine Research Society
ClinicalTrials.gov Identifier: NCT00639080     History of Changes
Other Study ID Numbers: Necessity for LLT
Study First Received: March 12, 2008
Last Updated: July 21, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Endocrine Research Society:
Type 2 diabetes
Dyslipidemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014