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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
St. Paul Heart Clinic
ClinicalTrials.gov Identifier:
NCT00123604
First received: July 21, 2005
Last updated: April 10, 2007
Last verified: April 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by St. Paul Heart Clinic:
beta-blockers
endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Carvedilol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on August 28, 2014