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

NCT00497003 | Completed Phase 4

• 1 other identifier: KF 02-071/03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Function; Beta Blocker

Keywords

Endothelial function; Beta blocker; Type 2 diabetes; Chronic heart failure

Outcome Measures

Primary Outcomes (1)

• Endothelial function and insulin stimulated endothelial function

  2 months

Secondary Outcomes (1)

• Insulin stimulated glucose uptake

  2 months

Interventions

Treatment with either metoprolol or carvedilol DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Chronic heart failure

You may not qualify if:

• 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,

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Danish Heart Foundation: collaborator

Study Sites (1)

Department of Cardiology, University Hospital of Copenhagen, Bispebjerg

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 21999413 DERIVED

• 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.

  PMID: 20500877 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Therapeutics; Carvedilol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Christian Torp-Pedersen, MD, DSc

  Department of Cardiology, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: February 1, 2004
• Study Completion: October 1, 2007
• Last Updated: October 15, 2007

Record last verified: 2007-07

Locations

DK (1)