Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
Information source: Bispebjerg Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endothelial Function; Beta Blocker
Intervention: Treatment with either metoprolol or carvedilol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bispebjerg Hospital Official(s) and/or principal investigator(s):
Christian Torp-Pedersen, MD, DSc, Principal Investigator, Affiliation: Department of Cardiology, Bispebjerg Hospital
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.
Clinical Details
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Endothelial function and insulin stimulated endothelial function
Secondary outcome: Insulin stimulated glucose uptake
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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,
Locations and Contacts
Department of Cardiology, University Hospital of Copenhagen, Bispebjerg, Copenhagen 2400, Denmark
Additional Information
Starting date: February 2004
Ending date: October 2007
Last updated: October 12, 2007
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