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Comparison of Blood Pressure Medications on Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen Colleran, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00642434
First received: March 21, 2008
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation.

Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler


Condition Intervention Phase
Diabetes
 Drug: carvedilol
Drug: metoprolol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Carvedilol vs.Metoprolol: A Comparison of Effects on Endothelial Function and Oxidative Stress in Response to Acute Hyperglycemia in Patients With Type 2 Diabetes and Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • change in endothelial function [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: January 2004
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
study drug
 Drug: carvedilol
variable
Active Comparator: 2
study drug
 Drug: metoprolol
variable

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • not enrolling

Exclusion Criteria:

  • not enrolling
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642434

Locations
United States, New Mexico
UNMHSC
Albquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
  More Information

No publications provided

Responsible Party: Kathleen Colleran, Professor of Medicine, University of New Mexico
ClinicalTrials.gov Identifier: NCT00642434     History of Changes
Other Study ID Numbers: UNM04094
Study First Received: March 21, 2008
Last Updated: August 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
diabetes blood pressure oxidative stress

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System 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 May 23, 2013