Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and vessel wall thickness in patients with type 2 diabetes mellitus - SIMTAC

Conditions: diabetes mellitus type 2
MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

Registration Number: EUCTR2008-004853-13-NL

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

diabetes mellitus type 2 treated with metformin alone or in combination with SU-derivate
HbA1c< 8.5%
well regulated blood pressure
BMI >20 kg/m2 and <35 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

use of insulin or thiazolidinediones
use of fibrates or statins one year prior to the study
hereditary lipoprotein disease
renal disease: creatinine clearance<60 ml/min or creatinine>100 micromol/l
allergy to intravenous contrast
metal implants, claustrophobia or other contraindications for MRI
any significant chronic disease, hepatic disease or other endocrine disease
pregnancy/lactation
psychiatric disorders and/or use of antipsychotic or antidepressant drugs
recent participation in other research projects in the last 3 months or participation in 2 or more projects in one year

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of simvastatin on myocardial triglyceride accumulation and cardiac function in diabetes mellitus type 2 using MRI and MR spectroscopy;Secondary Objective: To study the effect of simvastatin on:<br>- total vessel wall area and thickness <br>- liver triglyceride content<br>;Primary end point(s): Difference in the following end-points after placebo or simvastatine in:<br>myocardial triglyceride content<br>heart dimensions<br>systoloic and diastolic heart function

Secondary Outcome Measures