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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123604
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., St. Paul Heart Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Type 2 Diabetes Mellitus Drug: Carvedilol Drug: Metoprolol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus
Study Start Date : June 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Arm Intervention/treatment
Experimental: Carvedilol
Carvedilol, orally, 25 mg, twice daily for five months
Drug: Carvedilol
25 mg twice daily for five months.
Other Name: Coreg
Active Comparator: Metoprolol
Metoprolol, orally, 200 mg, twice daily for five months.
Drug: Metoprolol
200 mg twice daily for five months.
Other Name: Lopressor

Primary Outcome Measures :
  1. Flow Mediated Dilation [ Time Frame: change from baseline to 5 months ]
    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.

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00123604

United States, Minnesota
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
Sponsors and Collaborators
St. Paul Heart Clinic
Principal Investigator: Alan J Bank, M.D. St. Paul Heart Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Aaron S. Kelly, Ph.D., Senior Research Scientist, St. Paul Heart Clinic Identifier: NCT00123604     History of Changes
Other Study ID Numbers: GSK101598
First Posted: July 25, 2005    Key Record Dates
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Aaron S. Kelly, Ph.D., St. Paul Heart Clinic:
endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists