Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
Not Applicable
Completed
- Conditions
- HypercholesterolemiaDiabetesCardiovascular Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT00704314
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
We aimed to address the issue whether statins affect insulin resistance. To this end, we combined the available state-of-the art technology for detailed assessment of both whole-body and tissue specific insulin sensitivity in vivo in humans (euglycemic-hyperinsulinemic clamp, stable isotope \[6,6-2H2\]glucose dilution technique, proton nuclear magnetic resonance spectroscopy - 1H MRS - of liver and skeletal muscle). Outcome measures were determined before and after 8 weeks therapy with 80 mg Simvastatin in hypercholesterolemic patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Type 2 diabetic patients with known duration of disease: 3-10 years
- Age: 35-75 years
- BMI<32 kg/m2
- Hypercholesterolemia: fasting serum low density lipoprotein (LDL)
- Cholesterol concentration < 4.16 mmol/L (<160 mg/dl)
- Normotriglyceridemia: fasting plasma triglyceride concentration < 2.75 mmol/L (250 mg/dl)
- Creatinine levels < 1.8 mg /dl
- Liver transaminases < 20% over the upper limit with no active liver disease and CK < 50% above the upper limit
- Blood pressure less than 160/100 mmHg were accepted as eligible for enrollment
Exclusion Criteria
- Hypertension, cardiovascular disease or metabolic diseases other than T2DM as determined by medical history, physical examination and routine laboratory tests
- Alcohol consumption (more than 10 drinks/week)
- Poor glycemic control (HbA1c<9%)
- Patients requiring insulin, patients with type 1 diabetes
- Patients taking any medicine known to interfere with metabolism of statins or with insulin sensitivity as summarized in an exclusionary drug table
- Patients receiving any hypolipidemic medication or diet during the last 2 months before enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo, one pill daily for 8 weeks 1 Simvastatin Simvastatin therapy, 80 mg/d for 8 weeks
- Primary Outcome Measures
Name Time Method insulin sensitivity 8 weeks
- Secondary Outcome Measures
Name Time Method ectopic lipid deposition in liver and muscle 8 weeks
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria