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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of High Dose Simvastatin Therapy on Glucose Metabolism and Ectopic Lipid Deposition in Non-Obese Type 2 Diabetic Patients

Conditions
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Hypercholesterolemia, Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Simvastatin therapy, 80 mg/d for 8 weeks | Drug: Simvastatin<br>* 80 mg Simvastatin daily for 8 weeks<br>* Other names: Zocord;|
| Placebo Comparator: 2<br>Placebo, one pill daily for 8 weeks | Drug: Placebo<br>* The placebo was identical in appearance and was provided by the same manufacturer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ectopic lipid deposition in liver and muscle |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin resistance, Statins, Muscle and liver triglycerides