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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00704314
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : June 24, 2008
Austrian Science Fund (FWF)
European Foundation for the Study of Diabetes
EU grant
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of Vienna

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 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Diabetes Cardiovascular Disease Drug: Simvastatin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of High Dose Simvastatin Therapy on Glucose Metabolism and Ectopic Lipid Deposition in Non-Obese Type 2 Diabetic Patients
Study Start Date : October 2002
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Active Comparator: 1
Simvastatin therapy, 80 mg/d for 8 weeks
Drug: Simvastatin
80 mg Simvastatin daily for 8 weeks
Other Name: Zocord

Placebo Comparator: 2
Placebo, one pill daily for 8 weeks
Drug: Placebo
The placebo was identical in appearance and was provided by the same manufacturer

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. ectopic lipid deposition in liver and muscle [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00704314

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Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Austrian Science Fund (FWF)
European Foundation for the Study of Diabetes
EU grant
Merck Sharp & Dohme Corp.
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Principal Investigator: Werner Waldhäusl, Prof, MD Medical University of Vienna

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Werner Waldhäusl, Prof. Dr. Michael Roden, Hanusch Hospital, 1. Medical Department, Vienna Austria Identifier: NCT00704314    
Other Study ID Numbers: EK: 258/2002
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008
Keywords provided by Medical University of Vienna:
Insulin resistance
Muscle and liver triglycerides
Additional relevant MeSH terms:
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Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors