Back to resultsDoes Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
Primary Purpose
Hypercholesterolemia, Diabetes, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring Insulin resistance, Statins, Muscle and liver triglycerides
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Simvastatin therapy, 80 mg/d for 8 weeks
Placebo, one pill daily for 8 weeks
Outcomes
Primary Outcome Measures
insulin sensitivity
Secondary Outcome Measures
ectopic lipid deposition in liver and muscle
Full Information
NCT ID
NCT00704314
First Posted
June 23, 2008
Last Updated
June 23, 2008
Sponsor
Medical University of Vienna
Collaborators
Austrian Science Fund (FWF), European Foundation for the Study of Diabetes, EU grant, Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00704314
Brief Title
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
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
Collaborators
Austrian Science Fund (FWF), European Foundation for the Study of Diabetes, EU grant, Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Diabetes, Cardiovascular Disease
Keywords
Insulin resistance, Statins, Muscle and liver triglycerides
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Simvastatin therapy, 80 mg/d for 8 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo, one pill daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocord
Intervention Description
80 mg Simvastatin daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo was identical in appearance and was provided by the same manufacturer
Primary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
ectopic lipid deposition in liver and muscle
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Waldhäusl, Prof, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
18957532
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.
Results Reference
derived
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Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
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