Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome

NCT00775671 | Completed Phase 4 Results

• 1 other identifier: 080496
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Marker of Fibrinolysis

  Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.

  After 12 weeks of study drug

Secondary Outcomes (1)

• Measurement of Insulin Sensitivity

  3 hours

Study Arms (2)

Nebivolol

ACTIVE COMPARATOR

Nebivolol 5mg by mouth daily for 12 weeks.

Drug: placebo; Drug: Nebivolol

Metoprolol

ACTIVE COMPARATOR

Metoprolol ER 100mg by mouth daily for 12 weeks.

Drug: placebo; Drug: Metoprolol

Interventions

placebo DRUG

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.

Metoprolol; Nebivolol

Nebivolol DRUG

Nebivolol 5 mg by mouth daily for 12 weeks.

Nebivolol

Metoprolol DRUG

Metoprolol ER 100mg by mouth daily for 12 weeks.

Metoprolol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory subjects, 18 to 70 years of age, inclusive
• 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
• 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

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• 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
• Use of hormone replacement therapy
• Change in statin therapy within the last 6 months
• In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg
• Pregnancy
• Breast-feeding
• 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
• Treatment with anticoagulants
• History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
• History or presence of immunological or hematological disorders
• Diagnosis of asthma
• Clinically significant gastrointestinal impairment that could interfere with drug absorption
• Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino transaminase \[ALT\] \>2.0 x upper limit of normal range)
• Impaired renal function (serum creatinine \>1.5 mg/dl)

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Ayers K, Byrne LM, DeMatteo A, Brown NJ. Differential effects of nebivolol and metoprolol on insulin sensitivity and plasminogen activator inhibitor in the metabolic syndrome. Hypertension. 2012 Apr;59(4):893-8. doi: 10.1161/HYPERTENSIONAHA.111.189589. Epub 2012 Feb 21.

  PMID: 22353614 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Nebivolol; Metoprolol

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols

Results Point of Contact

• Title: Nancy J Brown
• Organization: Vanderbilt University

nancy.j.brown@vanderbilt.edu

615-343-8701

Study Officials

• Nancy J Brown

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 23, 2012
• Results First Posted: October 23, 2012

Record last verified: 2012-09

Locations

US (1)