Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: Austrian Science Fund (FWF); EU grant; European Foundation for the Study of Diabetes; Merck Sharp & Dohme Corp.
• Treatments: Simvastatin

Criteria

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