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Sponsors and Collaborators: |
University of Southern Denmark Pfizer |
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Information provided by: | University of Southern Denmark |
ClinicalTrials.gov Identifier: | NCT00124397 |
The aim of this study is to examine the effect of intensive cholesterol lowering therapy and tight blood pressure (BP) regulation on endothelial function (inner cell layer of vessels that determines dilatation) in type 2 diabetic patients without documented cardiovascular (CV) disease. The hypothesis is that intensive cholesterol lowering and tight blood pressure regulation will due better than a control group.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: Atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of High Dose Statin Therapy on Endothelial Function in Patients With Type 2 Diabetes Mellitus Without CAD |
Estimated Enrollment: | 186 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | December 2004 |
Background:The prevalence of diagnosed type 2 diabetes mellitus (DM) is estimated to 2-4% in the general population in most European countries. DM is associated with an increased frequency of manifest atherosclerotic disease. Data from prospective studies demonstrate that the risk of developing acute coronary syndrome (ACS) in diabetic patients with no prior history of coronary artery disease (CAD) is equivalent to the risk observed in non-diabetics ACS survivors. Most diabetic patients die from CAD. Although DM is primarily a metabolic disorder, it imposes a tremendous burden on macro- and micro-vessel disease.The important question of primary prevention of cardiovascular disease (CVD) in DM remains unanswered.
In the major lipid-intervention studies where patients with CAD were included, the subgroup with DM had at least as good effect of lipid lowering therapy with statins as non-diabetics. The recently published Heart Protection Study supports the hypothesis of a favourable effect of statins in the primary prevention of CVD in DM. The UK Prospective Diabetic Study has proved that tight blood pressure (BP) regulation reduces the frequency of micro- and macrovascular endpoint. It has been suggested that combined lipid lowering with statins and tight BP regulation can have an additive effect in DM patients. It is well established that the atherosclerotic process has an impact on endothelial function.An improvement of endothelial function by cholesterol lowering and BP reduction may serve as a surrogate endpoint for CAD.
Objective:To assess the effect of intensive lipid lowering on endothelial function in patients with DM and serum cholesterol level <6.5 mmol/l and to evaluate the effect of combined lipid lowering and tight BP regulation on endothelial function in the same patient group.
Methods: This is a single-center, randomised, placebo-controlled study with three treatment arms. Participants are blindly allocated to: 1. atorvastatin 80 mg daily 2. corresponding placebo 3. open label treatment with atorvastatin 80 mg daily and tight BP regulation with 5-10 mg amlodipine, 2-4 mg perindopril, 4-8 mg doxazosin in mono- or combination therapy that aims BP <130/80.
Endothelial function is evaluated at baseline, at 6 and 12 month non-invasively. A high resolution ultrasound scan is performed on the right brachial artery to assess post ischemic flow mediated changes in arterial diameter. Flow mediated dilatation (FMD) depends on an intact endothelium and is mediated via endogenous nitric oxid (NO). To test non-endothelium dependent vasodilatation 0.4 mg of sublingual nitroglycerin (NG) is administrated. NG is a smooth muscle relaxant and acts as a source of NO.There is a well described relation tween endothelial function in the coronary arteries and in the brachial artery.
Sample size: the sample size in the study is based on the following assumptions:
Under these assumptions with a power of 80% and a 2 sided alfa of 5% a sample size of 160 patients are needed.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Svendborg | |
Department of Medical Research | |
SHF Svendborg, Svendborg, Denmark, 5700 |
Study Chair: | Kenneth Egstrup, MD | Department of Medical Research, SHF Svendborg |
Study ID Numbers: | 20000084, 2162 |
Study First Received: | July 26, 2005 |
Last Updated: | August 4, 2005 |
ClinicalTrials.gov Identifier: | NCT00124397 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
Antimetabolites Metabolic Diseases Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Coronary Artery Disease Atorvastatin |
Antimetabolites Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Atorvastatin |