NCT00123604

Brief Summary

The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

July 21, 2005

Results QC Date

June 29, 2012

Last Update Submit

November 17, 2014

Conditions

HypertensionType 2 Diabetes Mellitus

Keywords

beta-blockersendothelial function

Outcome Measures

Primary Outcomes (1)

  • Flow Mediated Dilation

    Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.

    change from baseline to 5 months

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol, orally, 25 mg, twice daily for five months

Drug: Carvedilol

Metoprolol

ACTIVE COMPARATOR

Metoprolol, orally, 200 mg, twice daily for five months.

Drug: Metoprolol

Interventions

CarvedilolDRUG

25 mg twice daily for five months.

Also known as: Coreg
Carvedilol
MetoprololDRUG

200 mg twice daily for five months.

Also known as: Lopressor
Metoprolol

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30-80 years old
  • Documented history of type 2 diabetes
  • Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
  • Stable anti-diabetic regimen throughout the study period
  • Body mass index (BMI) between 22-45 kg/m2
  • HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
  • Screening blood pressure (BP) \> 130/80 (average of 3 sitting measurements), with current medications

You may not qualify if:

  • Uncontrollable or symptomatic arrhythmias
  • Unstable angina
  • Sick sinus syndrome or second or third degree heart block
  • Decompensated heart failure
  • Myocardial infarction (MI) or stroke within 3 months of screening
  • Bradycardia
  • Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids
  • Bronchial asthma or related bronchospastic conditions
  • New onset/diagnosed type 2 diabetes (\<3 months)
  • Clinically significant renal or liver disease (creatinine \>2.5 mg/dL)
  • Endocrine disorders
  • Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
  • Use of beta-blockers within 3 months of screening
  • Use of corticosteroids
  • Systemic disease, including cancer, with reduced life expectancy (\<12 months)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Related Publications (1)

  • Bank AJ, Kelly AS, Thelen AM, Kaiser DR, Gonzalez-Campoy JM. Effects of carvedilol versus metoprolol on endothelial function and oxidative stress in patients with type 2 diabetes mellitus. Am J Hypertens. 2007 Jul;20(7):777-83. doi: 10.1016/j.amjhyper.2007.01.019.

    PMID: 17586413DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

CarvedilolMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolamines

Limitations and Caveats

The sample size was relatively small

Results Point of Contact

Title
Aaron S. Kelly, Ph.D.
Organization
University of Minnesota
kelly105@umn.edu
612-626-3492

Study Officials

  • Alan J Bank, M.D.

    St. Paul Heart Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 18, 2014

Results First Posted

November 18, 2014

Record last verified: 2014-11

Locations

US(1)