Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT00854503
First received: March 2, 2009
Last updated: May 11, 2011
Last verified: January 2011
  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 Blind (Subject)
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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854503

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

No publications provided

Responsible Party: Davide Lauro, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT00854503     History of Changes
Other Study ID Numbers: 131/08
Study First Received: March 2, 2009
Last Updated: May 11, 2011
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Dyslipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Simvastatin
Rosuvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014