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

This study has been completed.

First Received: July 21, 2005 Last Updated: April 10, 2007 History of Changes

Sponsor:	St. Paul Heart Clinic
Collaborator:	GlaxoSmithKline
Information provided by:	St. Paul Heart Clinic
ClinicalTrials.gov Identifier:	NCT00123604

Purpose

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.

Condition	Intervention	Phase
Hypertension Type 2 Diabetes Mellitus	Drug: carvedilol Drug: metoprolol	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Metoprolol Metoprolol Tartrate Carvedilol Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by St. Paul Heart Clinic:

Primary Outcome Measures:

Improvement in endothelial function

Secondary Outcome Measures:

Improvement in markers of inflammation and oxidative stress

Estimated Enrollment:	36
Study Start Date:	June 2004
Estimated Study Completion Date:	February 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123604

Locations

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

Sponsors and Collaborators

St. Paul Heart Clinic

GlaxoSmithKline

Investigators

Principal Investigator:

Alan J Bank, M.D.

St. Paul Heart Clinic

More Information

No publications provided by St. Paul Heart Clinic

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bank AJ, Kelly AS, Thelen AM, Kaiser DR, Gonzalez-Campoy JM. Effects of carvedilol versus metoprolol on endothelial function and oxidative stress in patients with type 2 diabetes mellitus. Am J Hypertens. 2007 Jul;20(7):777-83.

Study ID Numbers:	GSK101598
Study First Received:	July 21, 2005
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00123604 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Paul Heart Clinic:

beta-blockers
endothelial function

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Sympatholytics
Metabolic Diseases
Vascular Diseases
Diabetes Mellitus

Endocrine System Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Metoprolol succinate
Diabetes Mellitus, Type 2
Adrenergic Antagonists
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010