Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Intervention: placebo; Nebivolol; Metoprolol
Intervention description: Placebo pill by mouth daily for 21 days followed by either Nebivolol 5 mg by mouth daily or metoprolol ER 100mg by mouth daily for 12 weeks.; Nebivolol 5 mg by mouth daily for 12 weeks.; Metoprolol ER 100mg by mouth daily for 12 weeks.
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin
      sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
    

Eligibility 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