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Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854503
First Posted: March 3, 2009
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Rome Tor Vergata
  Purpose
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.

Condition Intervention Phase
Type 2 Diabetes Diabetic Dyslipidemia Drug: Simvastatin Drug: Rosuvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • Glucose tolerance assessed by HbA1c and fasting glucose [ Time Frame: 1, 6, 12 months ]

Secondary Outcome Measures:
  • insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. [ Time Frame: 1, 6, 12 months. ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Simvastatin
Simvastatin 20 mg/day
Drug: Simvastatin
20 mg/day in one oral administration
Active Comparator: Rosuvastatin
Rosuvastatin 20 mg/day
Drug: Rosuvastatin
20 mg/day in one oral administration.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes in good glycemic control, treated with metformin alone.
  • Untreated dyslipidemia.
  • BMI <30.

Exclusion Criteria:

  • History of cancer.
  • History of cardiovascular diseases.
  • Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854503


Locations
Italy
University of Rome Tor Vergata
Rome, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
  More Information

Responsible Party: Davide Lauro, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT00854503     History of Changes
Other Study ID Numbers: 131/08
First Submitted: March 2, 2009
First Posted: March 3, 2009
Last Update Posted: May 12, 2011
Last Verified: January 2011

Keywords provided by University of Rome Tor Vergata:
Statins administration in diabetic dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors