View Clinical Trial (Medical Research Study)
The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetes
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Hypertension - Type 2 Diabetes |
| Purpose: |
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To examine changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in
Type 2 hypertensive diabetic patients as measured by the change from baseline in central
systolic blood pressure.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Age > 50
2. Established Type diabetics not treated with insulin
3. Stage I hypertensives
4. Normally active and judged to be in good health based on medical history and
routine lab tests
5. Must be on an optimal dose of a renin-angiotensin-system block before randomization
unless the patient is intolerant.
6. BMI < or equal to 35 or upper limit for arm circumference to address concern about
accuracy related to BP cuff fit
7. Hemoglobin A1C < or equal to 8.5.
8. Must be postmenopausal or taking some form of birth control or surgically sterile
9. Understands the procedures and requirements of the study by providing written
informed consent and authorization for protected health information disclosure. -
Exclusion Criteria:
1. Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
2. Active angina in the last 3 months.
3. Diabetes requiring treatment with insulin.
4. Severe asthma that has shown to exacerbate on previous beta blocker therapy or
asthmatics that have never been on a blockade.
5. Females who are pregnant, planning to be pregnant during the study period, lactating,
or women of childbearing potential who are not using a medically approved method of
contraception.
6. Uncontrolled hypertension.
7. Psychiatric disorders or medications (i.e., selective serotonin reuptake inhibitors)
which could interfere with the subject's compliance to the requirements of the
protocol, at the discretion of the Investigator.
8. Recent history of (within past 12 months) alcohol or substance abuse.
9. Has a condition the Investigator believes would interfere with evaluation of the
subject, or may put subject at undue risk.
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| NCT ID: |
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NCT01059916 |
| Primary Contact: |
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Principal Investigator
George Bakris, MD
University of Chicago
Carrie A. Schlaffer, BS, CCRC
Phone: 773-702-2591
Email: cschlaff@medicine.bsd.uchicago.edu
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| Backup Contact: |
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Email: rflynn@medicine.bsd.uchicago.edu
Rolanda Flynn, unknown
Phone: 773-834-4059
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| Location Contact: |
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Chicago, Illinois 60637
United States
Carrie A. Schlaffer, BS, CCRC
Phone: 773-702-2591
Email: cschlaff@medicine.uchicago.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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