Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients? - Full Text View

Sponsors and Collaborators:	Medical University of Vienna Austrian Science Foundation European Foundation for the Study of Diabetes (EFSD, GSK Grant) EU grant Merck Sharp and Dohme GesmbH
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00704314

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes Statins

Drug Information available for: Insulin Dextrose Simvastatin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Effects of High Dose Simvastatin Therapy on Glucose Metabolism and Ectopic Lipid Deposition in Non-Obese Type 2 Diabetic Patients

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
1: Active Comparator Simvastatin therapy, 80 mg/d for 8 weeks	Drug: Simvastatin 80 mg Simvastatin daily for 8 weeks
2: Placebo Comparator 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

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 Foundation

European Foundation for the Study of Diabetes (EFSD, GSK Grant)

EU grant

Merck Sharp and Dohme GesmbH

Investigators

Principal Investigator:

Werner Waldhäusl, Prof, MD

Medical University of Vienna

More Information

Responsible Party:	Hanusch Hospital, 1. Medical Department, Vienna Austria ( Prof. Dr. Werner Waldhäusl, Prof. Dr. Michael Roden )
Study ID Numbers:	EK: 258/2002
Study First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704314
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

Insulin resistance
Statins
Muscle and liver triglycerides

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Simvastatin
Diabetes Mellitus
Insulin Resistance
Metabolic disorder

Hypercholesterolemia
Cardiac Complexes, Premature
Insulin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009