Comparison of Blood Pressure Medications on Metabolism

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...

Date First Received: March 21, 2008

Last Updated: March 24, 2008

Verified by: University of New Mexico, March 2008

Clinical Trial Phase: Phase 4 | Start Date: January 2004

Overall Status: Active, not recruiting

Estimated Enrollment: 21

Brief Summary

Official Title: “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”

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

  • Drug: carvedilol
    • variable
  • Drug: metoprolol
    • variable

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • study drug
  • Active Comparator: 2
    • study drug

Outcome Measures for this Clinical Trial

Primary Measures

  • change in endothelial function
    • Time Frame: 5 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • not enrolling

Exclusion Criteria:

  • not enrolling

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: University of New Mexico

Additional Information

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642434

Study ID Number: UNM04094

ClinicalTrials.gov Identifier: NCT00642434

Health Authority: United States: Institutional Review Board

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