NCT00704314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
Last Updated

June 24, 2008

Status Verified

June 1, 2008

Enrollment Period

2.8 years

First QC Date

June 23, 2008

Last Update Submit

June 23, 2008

Conditions

HypercholesterolemiaDiabetesCardiovascular Disease

Keywords

Insulin resistanceStatinsMuscle and liver triglycerides

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    8 weeks

Secondary Outcomes (1)

  • ectopic lipid deposition in liver and muscle

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Simvastatin therapy, 80 mg/d for 8 weeks

Drug: Simvastatin

2

PLACEBO COMPARATOR

Placebo, one pill daily for 8 weeks

Drug: Placebo

Interventions

SimvastatinDRUG

80 mg Simvastatin daily for 8 weeks

Also known as: Zocord
1
PlaceboDRUG

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

2

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 receiving any hypolipidemic medication or diet during the last 2 months before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, A-1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 18957532DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDiabetes MellitusCardiovascular DiseasesInsulin Resistance

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Werner Waldhäusl, Prof, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 24, 2008

Study Start

October 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

June 24, 2008

Record last verified: 2008-06

Locations

AU(1)