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NCT00497003 Clinical Trial

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

Endothelial Function Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00497003
Other study ID # KF 02-071/03
Secondary ID
Status Completed
Phase Phase 4
First received July 5, 2007
Last updated October 12, 2007
Start date February 2004
Est. completion date October 2007

Study information
Verified date July 2007
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment with either metoprolol or carvedilol

Locations
Country Name City State
Denmark Department of Cardiology, University Hospital of Copenhagen, Bispebjerg Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Bispebjerg Hospital Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial function and insulin stimulated endothelial function 2 months
Secondary Insulin stimulated glucose uptake 2 months
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