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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Treatment with either metoprolol or carvedilol

Primary Measures

• Endothelial function and insulin stimulated endothelial function
  • Time Frame: 2 months
    

Secondary Measures

• Insulin stimulated glucose uptake
  • Time Frame: 2 months
    

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,

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bispebjerg Hospital

Overall Clinical Trial Officials and Contacts

Christian Torp-Pedersen, MD, DSc Principal Investigator Department of Cardiology, Bispebjerg Hospital  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00497003

Study ID Number: KF 02-071/03

ClinicalTrials.gov Identifier: NCT00497003

Health Authority: Denmark: Danish Medicines Agency