Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Endothelial function and insulin stimulated endothelial function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
Outcomes
Primary Outcomes
Endothelial function and insulin stimulated endothelial function
Time Frame: 2 months
Secondary Outcomes
- Insulin stimulated glucose uptake(2 months)