Trial | NCT00704314  Report issue

Title

Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
Effects of High Dose Simvastatin Therapy on Glucose Metabolism and Ectopic Lipid Deposition in Non-Obese Type 2 Diabetic Patients

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    simvastatin ...

  • Study Participants

    20
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.
Study Started
Oct 31
2002
Primary Completion
Jul 31
2005
Study Completion
Jul 31
2005
Last Update
Jun 24
2008
Estimate

Drug Simvastatin

80 mg Simvastatin daily for 8 weeks

  • Other names: Zocord

Drug Placebo

The placebo was identical in appearance and was provided by the same manufacturer

1 Active Comparator

Simvastatin therapy, 80 mg/d for 8 weeks

2 Placebo Comparator

Placebo, one pill daily for 8 weeks

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
No Results Posted