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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Endothelial Function Beta Blocker

Keywords

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Endothelial function Beta blocker Type 2 diabetes Chronic heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Treatment with either metoprolol or carvedilol

Intervention Type DRUG

Eligibility Criteria

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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,

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Christian Torp-Pedersen, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Bispebjerg Hospital

Locations

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Department of Cardiology, University Hospital of Copenhagen, Bispebjerg

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Falskov B, Hermann TS, Raunso J, Christiansen B, Rask-Madsen C, Major-Pedersen A, Kober L, Torp-Pedersen C, Dominguez H. Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure--a randomized study. Cardiovasc Diabetol. 2011 Oct 15;10:91. doi: 10.1186/1475-2840-10-91.

Reference Type DERIVED

PMID: 21999413 (View on PubMed)

Kveiborg B, Hermann TS, Major-Pedersen A, Christiansen B, Rask-Madsen C, Raunso J, Kober L, Torp-Pedersen C, Dominguez H. Metoprolol compared to carvedilol deteriorates insulin-stimulated endothelial function in patients with type 2 diabetes - a randomized study. Cardiovasc Diabetol. 2010 May 25;9:21. doi: 10.1186/1475-2840-9-21.