A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus.

Completed

• Conditions: on-insulin dependent diabetes mellitus (NIDDM)

• Registration Number: NL-OMON20255
• Lead Sponsor: eiden University Medical Center, Dept. of General Internal Medicine and dept. of Cardiology.

Brief Summary

Beishuizen ED, van de Ree MA, Jukema JW, Tamsma JT, van der Vijver JC, Meinders AE, Putter H, Huisman MV. Diabetes Care 2004;27:2887-92.<br> -Beishuizen ED, Tamsma JT, Jukema JW, van de Ree MA, van der Vijver JC, Meinders AE, Huisman MV. Diabetes Care 2005;28:1668-74.<br> -Beishuizen ED, Jukema JW, Tamsma JT, van de Ree MA, van der Vijver JC, Putter H, Maan AC, Meinders AE, Huisman MV. Diabetes Care 2005;28:1675-9.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

1. Patient with Non-Insulin Dependent Diabetes Mellitus. The diagnosis based upon the age of onset, the presence of obesity and the absence of ketoacidosis at the time of diagnosis and the use of diet or oral anti-diabetic drugs for more than one year from diagnosis;

2. Males and females;

Exclusion Criteria

1. Angina pectoris;

2. History of myocardial infarction, PTCA or CABG;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of IMT and distensibility after 24 months using B-mode ultrasound at the carotid artery level.

Secondary Outcome Measures

Name	Time	Method
1. The change in the prevalence of (silent) myocardial ischemia after 24 months as monitored with 48h-ambulatory ECG;<br /><br>2. The change of endothelium function after 24 months using flow mediated vasodilation assessed by ultrasound of the a. brachialis;<br /><br>3. The change in blood levels of parameters for endothelial function, haemostasis, fibrinolysis, platelet activation, endothelial cell injury and vascular wall inflammation;<Br><br>4. Biochemical endpoints: total cholesterol, HDL-cholesterol, (calculated) LDL-cholesterol, triglycerides, LDL/ApoB100 ratio, LpA-I, Lp(a);<br /><br>5. Diabetic nephropathy: Creatinine clearance and microalbuminuria;<bR><br>6. Clinical endpoints of cardiovascular disease.