Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients

NCT00639080 | Completed

• 1 other identifier: Necessity for LLT
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Dyslipidemia

Study Arms (1)

Entire study population

All study subjects.

Other: Stop lipid lowering therapy (statin)

Interventions

Stop lipid lowering therapy (statin) OTHER

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.

Entire study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Endocrine Research Society: lead

Study Sites (1)

Endocrine Research Society

Vancouver, British Columbia, V6E 1M7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Hugh Tildesley, MD

  St. Paul's Hospital, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2009-08

Locations

CA (1)