Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients - Full Text View

Sponsored by:	University of Rome Tor Vergata
Information provided by:	University of Rome Tor Vergata
ClinicalTrials.gov Identifier:	NCT00854503

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Statins

Drug Information available for: Simvastatin Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Simvastatin: Active Comparator Simvastatin 20 mg/day	Drug: Simvastatin 20 mg/day in one oral administration
Rosuvastatin: Active Comparator 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

Contacts

Contact: Alfonso Bellia, MD

bellia@med.uniroma2.it

Locations

Italy
University of Rome Tor Vergata	Recruiting
Rome, Italy, 00133
Contact: Alfonso Bellia, MD bellia@med.uniroma2.it
Sub-Investigator: Alfonso Bellia, MD
Sub-Investigator: Stefano Rizza, MD
Principal Investigator: Davide Lauro, MD
Sub-Investigator: Rossella Fabiano, MD
Sub-Investigator: Raffaella Rossi, MD

Sponsors and Collaborators

University of Rome Tor Vergata

More Information

No publications provided

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

Keywords provided by University of Rome Tor Vergata:

Statins administration in diabetic dyslipidemia

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Rosuvastatin
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009