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

Phase 4

Completed

• Conditions: Endothelial Function; Beta Blocker

• Registration Number: NCT00497003
• Lead Sponsor: Bispebjerg Hospital

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.

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 Timeline

• Study Start: 2004-02
• Status Verified: 2007-07
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2007-07-05
• Study First Posted: 2007-07-06
• Study Completion: 2007-10
• Last Update Submitted: 2007-10-12
• Last Update Posted: 2007-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial function and insulin stimulated endothelial function	2 months

Secondary Outcome Measures

Name	Time	Method
Insulin stimulated glucose uptake	2 months

Trial Locations

Locations (1)

Department of Cardiology, University Hospital of Copenhagen, Bispebjerg; 🇩🇰 Copenhagen, Denmark