Clinical trial NCT00497003: Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endothelial Function
Beta Blocker
Keywords: Endothelial function
Beta blocker
Type 2 diabetes
Chronic heart failure
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2007-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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,

Primary outcomes:
measure: Endothelial function and insulin stimulated endothelial function
timeFrame: 2 months
Secondary outcomes:
measure: Insulin stimulated glucose uptake
timeFrame: 2 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, University Hospital of Copenhagen, Bispebjerg
Study officials:
affiliation: Department of Cardiology, Bispebjerg Hospital
name: Christian Torp-Pedersen, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.