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

This study has been completed.
Sponsor:
Collaborators:
Austrian Science Fund (FWF)
European Foundation for the Study of Diabetes
EU grant
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00704314
First received: June 23, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 Intervention
Hypercholesterolemia
Diabetes
Cardiovascular Disease
Drug: Simvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ectopic lipid deposition in liver and muscle [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00704314

Locations
Austria
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.
Investigators
Principal Investigator: Werner Waldhäusl, Prof, MD Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Werner Waldhäusl, Prof. Dr. Michael Roden, Hanusch Hospital, 1. Medical Department, Vienna Austria
ClinicalTrials.gov Identifier: NCT00704314     History of Changes
Other Study ID Numbers: EK: 258/2002
Study First Received: June 23, 2008
Last Updated: June 23, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Insulin resistance
Statins
Muscle and liver triglycerides

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014