Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes

Hypertension Clinical Trial

Official title:

Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123604
• Other study ID #: GSK101598
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2005
• Last updated: November 17, 2014
• Start date: June 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2014
• Source: St. Paul Heart Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 30-80 years old

• Documented history of type 2 diabetes

• Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period

• Stable anti-diabetic regimen throughout the study period

• Body mass index (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 blood pressure (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

• Myocardial infarction (MI) or stroke within 3 months of screening

• Bradycardia

• Chronic obstructive pulmonary disease (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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Carvedilol
25 mg twice daily for five months.
• Metoprolol
200 mg twice daily for five months.

Locations

Country	Name	City	State
United States	St. Paul Heart Clinic	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
St. Paul Heart Clinic	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilation	Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.	change from baseline to 5 months	No