NCT00642434

Brief Summary

The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation. Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4 diabetes

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

January 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
15.5 years until next milestone

Results Posted

Study results publicly available

December 26, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

4.4 years

First QC Date

March 21, 2008

Results QC Date

April 11, 2012

Last Update Submit

December 7, 2023

Conditions

Keywords

diabetes blood pressure oxidative stress

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline

    Reporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline.

    5 months

Study Arms (2)

1

ACTIVE COMPARATOR

study drug- carvedilol

Drug: carvedilol

2

ACTIVE COMPARATOR

study drug metorprolol

Drug: metoprolol

Interventions

variable

Also known as: coreg, toprol
1

variable

2

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • not enrolling

You may not qualify if:

  • not enrolling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNMHSC

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

  • Colleran K, Aguirre L, Burge MR. Carvedilol vs. metoprolol: A comparison of effects on endothelial function and oxidative stress in response to acute hyperglycemia in patients with type 2 diabetes and hypertension. Journal of Diabetes Mellitus 2(1):146-151, 2012.

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

CarvedilolMetoprolol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Kathleen Colleran
Organization
University of New Mexico Health Sciences Center

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

January 1, 2004

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

December 26, 2023

Results First Posted

December 26, 2023

Record last verified: 2023-12

Locations