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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704314
• Other study ID #: EK: 258/2002
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: June 23, 2008
• Start date: October 2002
• Est. completion date: July 2005

Study information

• Verified date: June 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Hypercholesterolemia

Intervention

Drug:
• Simvastatin
80 mg Simvastatin daily for 8 weeks
• Placebo
The placebo was identical in appearance and was provided by the same manufacturer

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of Vienna	Austrian Science Fund (FWF), EU grant, European Foundation for the Study of Diabetes, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity		8 weeks	No
Secondary	ectopic lipid deposition in liver and muscle		8 weeks	No