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| Sponsor: | University of New Mexico |
|---|---|
| Information provided by (Responsible Party): | Kathleen Colleran, University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00642434 |
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: carvedilol Drug: metoprolol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| 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 |
| Enrollment: | 21 |
| Study Start Date: | January 2004 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
study drug
|
Drug: carvedilol
variable
|
|
Active Comparator: 2
study drug
|
Drug: metoprolol
variable
|
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Kathleen Colleran, Professor of Medicine, University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00642434 History of Changes |
| Other Study ID Numbers: | UNM04094 |
| Study First Received: | March 21, 2008 |
| Last Updated: | August 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
diabetes blood pressure oxidative stress |
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metoprolol Carvedilol Metoprolol succinate Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |