Status:
COMPLETED
Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Austrian Science Fund (FWF)
European Foundation for the Study of Diabetes
Conditions:
Hypercholesterolemia
Diabetes
Eligibility:
All Genders
21-70 years
Phase:
NA
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 specif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00704314
Start Date
October 1 2002
End Date
July 1 2005
Last Update
June 24 2008
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, A-1090