Recruiting

Coreg CR

Sponsor:

State University of New York - Downstate Medical Center

Code:

NCT00732511

Conditions

Endothelial Function

Diabetes Mellitus

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

carvedilol

metoprolol extended release

Study Details

Brief summary:

We are comparing the blood pressure-lowering effects of two marketed medications, Coreg CR and Toprol XL. Although both drugs reduce blood pressure by blocking the action of noradrenaline on beta-receptors in the blood vessels, Coreg CR also blocks alpha-receptors, which may provide added blood pressure-lowering. In addition, Coreg CR may have anti-oxidant actions. Cells which line blood vessels (termed "endothelial cells") make nitric oxide (NO), which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood pressure. When body cells use oxygen, they normally produce "free radicals", which can destroy NO,leading to high blood pressure, heart damage and worsenimg of diabetes. Antioxidants remove free radicals and prevent or repair this damage. In this study we will measure endothelial cell function, blood vessel wall stiffness, NO in exhaled breath, and blood levels of substances which reflect NO production and destruction to determine if a pure beta-blocker (Toprol XL) differs from an alpha/beta blocker (Coreg CR) in these effects. We will also examine the mechanism by which such differences might occur.

Conditions

Endothelial Function

Diabetes Mellitus

Hypertension

Study ID

NCT00732511

Start date

Apr, 2008

Status verified date

Feb, 2011

Completion date

Apr, 2009

Anticipated

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Type 2 diabetes mellitus,
2. Stable antidiabetic regimen for 3 months
3. Hemoglobin A1c <8.6%
4. Stable antihypertensive medication regimen for 3 months or more, including either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker

Exclusion Criteria:

1. Any clinically significant abnormality on history, physical examination, or laboratory testing which could preclude safe completion of the study
2. Significant cardiac conditions
3. Lung disease
4. Cigarette smoking
5. Chronic kidney disease (Stage 3 or greater)
6. Type 1 diabetes
7. Known contraindication to alpha- or beta-blocker therapy

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

experimental: 1

Coreg Cr will be up-titrated as needed to achieve blood pressure <130/80

active comparator: 2

Toprol XL will be up-titrated at weekly intervals to achieve a blood pressure <130/80 mm Hg

Interventions

carvedilol

capsules in doses of 20, 40, and 80 mg; once daily; 12 weeks duration

metoprolol extended release

tablets in doses 50, 100, and 200 mg; once daily; 12 weeks duration

Primary outcome measure

  • Effect of Coreg CR compared to Toprol XL on endothelial function, vascular compliance, and parameters of oxidative stress from time of randomization to study drug termination [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

SUNY Downstate Medical Center

Recruiting

Brooklyn, New York, United States, 11203

Contacts

More Information

Sponsor

State University of New York - Downstate Medical Center

Last update posted

Feb 10, 2011

Last verified

Feb, 2011

Keywords

  • Endothelial dysfunction
  • Blood vessel stiffness
  • Nitric oxide
  • Oxidative stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Downstate Medical Center on 2011-02-10.