Comparison of Blood Pressure Medications on Metabolism

Overview[ - collapse ][ - ]

Purpose 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
ConditionDiabetes
InterventionDrug: carvedilol
Drug: metoprolol
PhasePhase 4
SponsorUniversity of New Mexico
Responsible PartyUniversity of New Mexico
ClinicalTrials.gov IdentifierNCT00642434
First ReceivedMarch 21, 2008
Last UpdatedAugust 24, 2011
Last verifiedAugust 2011

Tracking Information[ + expand ][ + ]

First Received DateMarch 21, 2008
Last Updated DateAugust 24, 2011
Start DateJanuary 2004
Estimated Primary Completion DateJuly 2008
Current Primary Outcome Measureschange in endothelial function [Time Frame: 5 months] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of Blood Pressure Medications on Metabolism
Official TitleCarvedilol 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
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
ConditionDiabetes
InterventionDrug: carvedilol
variable
Drug: metoprolol
variable
Study Arm (s)
  • Active Comparator: 1
    study drug
  • Active Comparator: 2
    study drug

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment21
Estimated Completion DateJuly 2008
Estimated Primary Completion DateJune 2008
Eligibility Criteria
Inclusion Criteria:

- not enrolling

Exclusion Criteria:

- not enrolling
GenderBoth
Ages45 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00642434
Other Study ID NumbersUNM04094
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of New Mexico
Study SponsorUniversity of New Mexico
CollaboratorsNot Provided
Investigators Not Provided
Verification DateAugust 2011

Locations[ + expand ][ + ]

UNMHSC
Albquerque, New Mexico, United States, 87131