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

NCT ID: NCT00704314

Last Updated: 2008-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia Diabetes Cardiovascular Disease

Keywords

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Insulin resistance Statins Muscle and liver triglycerides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Simvastatin therapy, 80 mg/d for 8 weeks

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

80 mg Simvastatin daily for 8 weeks

2

Placebo, one pill daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Simvastatin

80 mg Simvastatin daily for 8 weeks

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Zocord

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austrian Science Fund (FWF)

OTHER

Sponsor Role collaborator

European Foundation for the Study of Diabetes

OTHER

Sponsor Role collaborator

EU grant

UNKNOWN

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Hanusch Hospital, 1. Medical Department, Vienna Austria

Principal Investigators

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Werner Waldhäusl, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 18957532 (View on PubMed)

Other Identifiers

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EK: 258/2002

Identifier Type: -

Identifier Source: org_study_id