The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: carvedilol and metoprolol	Phase IV

Further Study Details: 

Primary Outcomes: Improvement in endothelial function
Secondary Outcomes: Improvement in markers of inflammation and oxidative stress
Expected Total Enrollment:  36

Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Ages Eligible for Study:  30 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 30-80 years old
• Documented history of type 2 diabetes
• Stable ACE/ARB regimen 30 days before and throughout the study period
• Stable anti-diabetic regimen throughout the study period
• BMI between 22-45 kg/m2
• HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
• Screening BP > 130/80 (average of 3 sitting measurements), with current medications

Exclusion Criteria:

• Uncontrollable or symptomatic arrhythmias
• Unstable angina
• Sick sinus syndrome or second or third degree heart block
• Decompensated heart failure
• MI or stroke within 3 months of screening
• Bradycardia
• COPD with required inhaled or oral bronchodilators or corticosteroids
• Bronchial asthma or related bronchospastic conditions
• New onset/diagnosed type 2 diabetes (<3 months)
• Clinically significant renal or liver disease (creatinine >2.5 mg/dL)
• Endocrine disorders
• Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
• Use of beta-blockers within 3 months of screening
• Use of corticosteroids
• Systemic disease, including cancer, with reduced life expectancy (<12 months)
• Psychological illness/condition that interferes with comprehension of study requirements
• Use of an investigational drug within 30 days of entry into study

Please refer to this study by ClinicalTrials.gov identifier  NCT00123604

Aaron S Kelly, Ph.D.      651-310-1640    akelly@stphc.com

Minnesota
      St. Paul Heart Clinic, St. Paul,  Minnesota,  55102,  United States; Recruiting

Study chairs or principal investigators

Alan J Bank, M.D.,  Principal Investigator,  St. Paul Heart Clinic   

Study ID Numbers:  GSK101598
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 22, 2005
ClinicalTrials.gov Identifier:  NCT00123604
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26