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NCT Number: NCT00497003

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

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.

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Key information

Conditions

Endothelial Function Beta Blocker Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, University Hospital of Copenhagen, Bispebjerg

Copenhagen, 2400, Denmark

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Treatment with either metoprolol or carvedilol

Drug

Primary outcomes

  1. Endothelial function and insulin stimulated endothelial function

    Time frame: 2 months

Secondary outcomes

  1. Insulin stimulated glucose uptake

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Danish Heart Foundation

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Jul 6, 2007
Registry last updated
Oct 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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