Skip to main content
OpenTrials
Completed

NCT Number: NCT00704314

Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Cardiovascular Disease Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, A-1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

80 mg Simvastatin daily for 8 weeks

Other names: Zocord

Placebo

Drug

The placebo was identical in appearance and was provided by the same manufacturer

Primary outcomes

  1. insulin sensitivity

    Time frame: 8 weeks

Secondary outcomes

  1. ectopic lipid deposition in liver and muscle

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jun 24, 2008
Registry last updated
Jun 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.