Clinical trial NCT00704314: Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
Official title: Effects of High Dose Simvastatin Therapy on Glucose Metabolism and Ectopic Lipid Deposition in Non-Obese Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Diabetes
Cardiovascular Disease
Keywords: Insulin resistance
Statins
Muscle and liver triglycerides
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Austrian Science Fund (FWF)
name: European Foundation for the Study of Diabetes
name: EU grant
name: Merck Sharp & Dohme LLC
First posted: 2008-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: insulin sensitivity
timeFrame: 8 weeks
Secondary outcomes:
measure: ectopic lipid deposition in liver and muscle
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Werner Waldhäusl, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szendroedi J, Anderwald C, Krssak M, Bayerle-Eder M, Esterbauer H, Pfeiler G, Brehm A, Nowotny P, Hofer A, Waldhausl W, Roden M. Effects of high-dose simvastatin therapy on glucose metabolism and ectopic lipid deposition in nonobese type 2 diabetic patients. Diabetes Care. 2009 Feb;32(2):209-14. doi: 10.2337/dc08-1123. Epub 2008 Oct 28.