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

This study has been completed.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00497003
First received: July 5, 2007
Last updated: October 12, 2007
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Endothelial Function
Beta Blocker
 Drug: Treatment with either metoprolol or carvedilol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

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

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

Enrollment: 50
Study Start Date: February 2004
Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Bispebjerg Hospital

Additional 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
Study First Received: July 5, 2007
Last Updated: October 12, 2007
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013