Phase
Condition
Metabolic Syndrome
Obesity
Vascular Diseases
Treatment
Angiotensin-(1-7)
Saline
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females of all races between 18 and 60 years of age
Obesity defined as body mass index between 30-40 kg/m2
Insulin resistance defined as homeostasis model assessment 2 insulin resistance (HOMA2-IR) score >2.2
Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg, or by use of anti-hypertensive medications. This blood pressure cutoffwill allow us to include subjects with pre-hypertension.
Able and willing to provide informed consent
Exclusion
Exclusion Criteria:
Pregnancy or breast-feeding
Current smokers or history of heavy smoking (>2 packs/day)
History of alcohol or drug abuse
Morbid obesity (BMI > 40 kg/m2)
Previous allergic reaction to study medications
Evidence of type I or type II diabetes (i.e. fasting glucose >126 mg/dl, use ofanti-diabetic medications)
Cardiovascular disease other than hypertension 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
History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, ortransient ischemic attack
History or presence of immunological or hematological disorders
Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine aminotransaminase (ALT) > 2.0 x upper limit of normal range]
Impaired renal function (serum creatinine >1.5 mg/dl)
Anemia (hemoglobin <13.5 g/dl in males or <12.5 g/dl in females)
Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) ornorepinephrine transporter (NET) inhibitors
Treatment with phosphodiesterase 5 inhibitors
Treatment with anticoagulants
Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive daysin 1 month)
Treatment with any investigational drug in the 1 month preceding the study
Inability to give, or withdraw, informed consent
Other factors which in the investigator's opinion would prevent the subject fromcompleting the protocol (i.e., clinically significant abnormalities on clinical,mental examination or laboratory testing or inability to comply with protocol)
Study Design
Study Description
Connect with a study center
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Vanderbilt University School of Medicine
Nashville, Tennessee 37232
United StatesActive - Recruiting
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