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Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome
This study is currently recruiting participants.
Verified by Vanderbilt University, October 2008
Sponsored by: Vanderbilt University
Information provided by: 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

Drug Information available for: Insulin Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Nebivolol
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title: Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Markers of fibrinolysis in the blood [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurements of insulin sensitivity [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: October 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Nebivolol and placebo
Drug: nebivolol and placebo
Placebo for 21 days and nebivolol 5 mg/day for 12 weeks
2: Active Comparator
Metoprolol and placebo
Drug: metoprolol and placebo
Placebo for 21 days and metoprolol 100mg/day for 12 weeks

Detailed Description:
  1. Test the hypothesis that nebivolol treatment decreases PAI-1 antigen and activity and improves fibrinolytic balance compared to metoprolol treatment in individuals with metabolic syndrome.
  2. Test the hypothesis that nebivolol treatment improves insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ambulatory subjects, 18 to 70 years of age, inclusive
  2. For female subjects, the following conditions must be met:

    • postmenopausal status for at least 1 year, or
    • status-post surgical sterilization, or
    • if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day
  3. Metabolic syndrome as defined by 3 or more of the following:

    • Fasting plasma glucose of at least 100 mg/dL (5.5 mmol/L)
    • Serum triglycerides of at least 150 mg/dL (1.7 mmol/L)
    • Serum HDL cholesterol less than 40 mg/dL (1.04 mmol/L) in men and 50 mg/dL in women
    • Blood pressure of at least 130/85 mmHg
    • Waist girth of more than 102 cm in men or 88 cm in women

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater or the use of anti-diabetic medication
  2. Use of hormone replacement therapy
  3. Change in statin therapy within the last 6 months
  4. In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg
  5. Pregnancy
  6. Breast-feeding
  7. Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
  8. Treatment with anticoagulants
  9. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
  10. History or presence of immunological or hematological disorders
  11. Diagnosis of asthma
  12. Clinically significant gastrointestinal impairment that could interfere with drug absorption
  13. Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >2.0 x upper limit of normal range)
  14. Impaired renal function (serum creatinine >1.5 mg/dl)
  15. Hematocrit <35%
  16. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
  17. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
  18. Treatment with lithium salts
  19. History of alcohol or drug abuse
  20. Treatment with any investigational drug in the 1 month preceding the study
  21. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
  22. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
  23. Inability to swallow capsules
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775671

Contacts
Contact: Loretta M Byrne 615-322-2105 loretta.byrne@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Nancy J Brown Vanderbilt University
  More Information

Responsible Party: Vanderbilt University Medical Ctr. Div. of Clinical Pharmacology ( Nancy J. Brown M/D. )
Study ID Numbers: 080496
Study First Received: October 17, 2008
Last Updated: October 17, 2008
ClinicalTrials.gov Identifier: NCT00775671  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metoprolol succinate
Nebivolol
Metoprolol
Insulin

Additional relevant MeSH terms:
Vasodilator Agents
Sympatholytics
Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Syndrome
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009