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Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure

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.
ClinicalTrials.gov Identifier: NCT00497003
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : October 15, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

The aim of this study is to evaluate the effect of the two different beta blockers metoprolol and carvedilol on endothelial function in patients with either type two diabetes or chronic heart failure.

Hypothesis: 1* Carvedilol compared to metoprolol has a favourable effect on endothelial function.

2* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated endothelial function.

The study is conducted as an open parallel group study. Endothelial function and insulin stimulated endothelial function was evaluated before and after a two months treatment period with either of the two beta blockers.


Condition or disease Intervention/treatment Phase
Endothelial Function Beta Blocker Drug: Treatment with either metoprolol or carvedilol Phase 4

Detailed Description:

Endothelial function is deteriorated in patients with type 2 diabetes and in patients with chronic heart failure. Treatment with carvedilol improves survival in patients with chronic heart failure compared to treatment with metoprolol. Carvedilol improves metabolic glucose control in patients with diabetes compared to metoprolol.Carvedilol compared to metoprolol also decreases the number of patients with new onset diabetes among patients with chronic heart failure. The mechanism behind these findings has not been fully understood.

The purpose of this study is to investigate if carvedilol compared to metoprolol has a favourable effect on endothelial function and insulin stimulated endothelial function, in groups of patients with either diabetes or chronic heart failure.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2004
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Endothelial function and insulin stimulated endothelial function [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Insulin stimulated glucose uptake [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Chronic heart failure

Exclusion Criteria:

  • For patients with type 2 diabetes:

    * Vascular complications.

  • For patients with chronic heart failure:

    • Severe uncontrolled heart failure.
    • Untreated severe hypertension, hypotension.
    • Bradycardia.
    • Known intolerance to beta blocker treatment.
    • Pregnancy,
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00497003


Locations
Denmark
Department of Cardiology, University Hospital of Copenhagen, Bispebjerg
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Danish Heart Foundation
Investigators
Principal Investigator: Christian Torp-Pedersen, MD, DSc Department of Cardiology, Bispebjerg Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00497003     History of Changes
Other Study ID Numbers: KF 02-071/03
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: October 15, 2007
Last Verified: July 2007

Keywords provided by Bispebjerg Hospital:
Endothelial function
Beta blocker
Type 2 diabetes
Chronic heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Metoprolol
Carvedilol
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists