Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: nebivolol and placebo (Drug); metoprolol and placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Nancy J Brown, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Loretta M Byrne, Phone: 615-322-2105, Email: loretta.byrne@vanderbilt.edu
Summary
Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin
sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
Clinical Details
Official title: Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Markers of fibrinolysis in the blood
Secondary outcome: Measurements of insulin sensitivity
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Loretta M Byrne, Phone: 615-322-2105, Email: loretta.byrne@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Additional Information
Starting date: October 2008
Ending date: April 2010
Last updated: April 14, 2009
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