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

June 23, 2008 updated by: Medical University of Vienna

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Simvastatin therapy, 80 mg/d for 8 weeks
Drug: Simvastatin
80 mg Simvastatin daily for 8 weeks
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin sensitivity
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ectopic lipid deposition in liver and muscle
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Merck Sharp & Dohme LLC
European Foundation for the Study of Diabetes
Austrian Science Fund (FWF)
EU grant

Investigators

  • Principal Investigator: Werner Waldhäusl, Prof, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2008

Last Update Submitted That Met QC Criteria

June 23, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK: 258/2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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