Coreg CR, Blood Vessel Stiffness and Blood Vessel Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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The following techniques will be used:

Endothelial function will be measured non-invasively by flow-mediated changes in pulsatile blood volume in the finger-tips.

Vascular compliance (stiffness) will be assessed by tonometry of the radial pulse wave ("augmentation index") and diastolic puse wave analysis.

Plasma nitrate/nitrite levels mirror NO production and will be measured spectrophotometrically by the Griess reaction.

Plasma nitrotyrosine, an in vivo marker of NO-dependent damage induced by reactive nitrogen intermediates derived from NO, will be measured by ELISA.

Exhaled NO may provide an real-time measure of endothelial cell NO production and can be measured by a hand-held device which contains an electrochemical detector sensitive to 5 ppb.

Conditions

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Endothelial Function Diabetes Mellitus Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

carvedilol

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

metoprolol extended release

Intervention Type DRUG

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

Interventions

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carvedilol

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

Intervention Type DRUG

metoprolol extended release

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

Intervention Type DRUG

Other Intervention Names

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Coreg CR Toprol XL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No