Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and al vessel wall thickness in patients with type 2 diabetes mellitus
- Conditions
- diabetes mellitus complications100192801001265310003216
- Registration Number
- NL-OMON32611
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
• Informed consent
• DM2 treated with metformin or metformin in combination with SU- derivate
• HbA1c<8.5 %
• BMI> 20kg/m2 and <35 kg/m2
• Well regulated blood pressure (i.e. RR<140/90)
• Use of insulin or thiazolidinediones (TZD)
• Use of fibrates or statins one year prior to study
• Hereditary lipoprotein disease
• Psychiatric disorders and/or use of antipsychotic or antidepressant drugs at present or in the past
• Renal disease (plasma creatinine levels>100µmol or clearance <= 60 ml/min) hepatic disease (ASAT/ALAT > 2 times reference values) or other endocrine disease
• Any significant chronic disease
• Any significant abnormal laboratory results found during the medical screening procedure
• Pregnancy/ lactation
• Allergy to intravenous contrast
• Claustrophobia
• Metal implants or other contraindications for MRI
• Recent participation in other research projects within the last 3 months or participation in 2 or more projects in one year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>• Myocardial triglyceride content<br /><br>• Heart dimensions<br /><br>• Heart function: systolic and diastolic</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br />• Aortic distensibility and pulse wave velocity<br />• Total vessel wall area and thickness<br />• Liver triglyceride content<br />• Body fat distribution</p>