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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by (Responsible Party): | Nancy J. Brown, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00775671 |
Purpose
Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: nebivolol and placebo Drug: metoprolol and placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome |
| Enrollment: | 46 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Nebivolol and placebo
|
Drug: nebivolol and placebo
Placebo for 21 days and nebivolol 5 mg/day for 12 weeks
|
|
Active Comparator: 2
Metoprolol and placebo
|
Drug: metoprolol and placebo
Placebo for 21 days and metoprolol 100mg/day for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For female subjects, the following conditions must be met:
Metabolic syndrome as defined by 3 or more of the following:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Nancy J Brown | Vanderbilt University |
More Information
| Responsible Party: | Nancy J. Brown, Professor of Medicine and Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00775671 History of Changes |
| Other Study ID Numbers: | 080496 |
| Study First Received: | October 17, 2008 |
| Last Updated: | September 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Metoprolol Nebivolol 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 |