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OpenTrials
Completed

NCT Number: NCT00854503

Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Dyslipidemia Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rome Tor Vergata

Rome, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

20 mg/day in one oral administration

Rosuvastatin

Drug

20 mg/day in one oral administration.

Primary outcomes

  1. Glucose tolerance assessed by HbA1c and fasting glucose

    Time frame: 1, 6, 12 months

Secondary outcomes

  1. insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.

    Time frame: 1, 6, 12 months.

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 3, 2009
Registry last updated
May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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