Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Isosorbide (Drug); Sildenafil (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Nancy J Brown, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Delia M Woods, BSN, Phone: 615-322-3371, Email: delia.woods@vanderbilt.edu
Summary
The purpose of the study is to determine if giving isosorbide,a drug that is used to treat
chest pain, affects blood vessel release of an anti-clotting factor.
Clinical Details
Official title: Renin-Angiotensin Aldosterone System and Fibrinolysis(RAAS) Interaction in Humans- Specific Aim 3
Study design: Health Services Research, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Primary outcome: Measure tPA release
Secondary outcome: Measurement of forearm flow
Detailed description:
To test the hypothesis that the administration of the NO donor isosorbide dinitrate,but not
the phosphodiesterase inhibitor sildenafil, will attenuate stimulated vascular t-PA release
during ACE inhibition whereas both agents will improve glucose uptake.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18-70 years of age
- Male and female subjects
- Surgical sterilization
- Childbearing potential: beta HCg on study day
- Subjects with a BMI of 25 or greater
Exclusion Criteria:
- Diabetes type 1 to 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
- Statin therapy
- In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHG or a
seated diastolic blood pressure greater than 110 mm Hg or taking hypertensives
- Pregnancy/Breast Feeding
- Cardiovascular disease such as myocardial infarction with 6 months prior to
enrollment, presence of angina pectoris, significant arrhythmia, congestive heart
failure (LV hypertrophy acceptable) deep vein thrombosis, pulmonary embolism, second
or three 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
- Diagnosis of asthma
- Clinically significant gastrointestinal impairment that could interfere with drug
absorption
- Hematocrit <35%
- Hyperlipidemic fasting Total Cholesterol >220
- Impaired renal function (Serum creatinine >1. 5 mg/dl)
- History or presence of immunological or hematological disorders
- Any underlying or acute disease requiring regular medication which could possible pose
a threat to the subject or make implementation of the protocol or interpretation of
the study results difficult
- Impaired hepatic function (SGOT, SGPT > 60)
- Treatment with chronic systemic glucocorticoid therapy (more than 7 days in 1 month)
- Treatment with lithium salts
- History of Alcohol or drug abuse
- Treatment with any investigational drug 1 month preceding study
- Mental conditions rendering the subject unable to understand the nature, scope and
possible consequences of the study
- Inability to comply with the protocol
Locations and Contacts
Delia M Woods, BSN, Phone: 615-322-3371, Email: delia.woods@vanderbilt.edu
Vanderbilt University Medical Center-GCRC, Nashville, Tennessee 37232, United States; Recruiting
Additional Information
Starting date: April 2008
Ending date: April 2010
Last updated: May 28, 2008
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