Cardiovascular Disease, Diabetes, Hypercholesterolemia
Conditions
Keywords
Insulin resistance, Statins, Muscle and liver triglycerides
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.
Interventions
DRUGSimvastatin
80 mg Simvastatin daily for 8 weeks
DRUGPlacebo
The placebo was identical in appearance and was provided by the same manufacturer
Sponsors
Austrian Science Fund (FWF)
European Foundation for the Study of Diabetes
EU grant
Merck Sharp & Dohme LLC
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insulin sensitivity | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| ectopic lipid deposition in liver and muscle | 8 weeks |
Countries
Austria
Outcome results
None listed