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):
Intervention(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
- Time Frame: 5 months
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
Clinical Trials Authorship and Review
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