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

July 5, 2007
October 12, 2007
February 2004
Not Provided
Endothelial function and insulin stimulated endothelial function [ Time Frame: 2 months ]
Same as current
Complete list of historical versions of study NCT00497003 on ClinicalTrials.gov Archive Site
Insulin stimulated glucose uptake [ Time Frame: 2 months ]
Same as current
Not Provided
Not Provided
 
Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
Not Provided

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Endothelial Function
  • Beta Blocker
Drug: Treatment with either metoprolol or carvedilol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2007
Not Provided

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,
Both
40 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00497003
KF 02-071/03
No
Not Provided
Bispebjerg Hospital
Danish Heart Foundation
Principal Investigator: Christian Torp-Pedersen, MD, DSc Department of Cardiology, Bispebjerg Hospital
Bispebjerg Hospital
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP