Recruiting nowEarly Phase 1Interventional
What this study is about
Obesity is a global health concern that is associated with high blood pressure and an increased risk for developing cardiovascular disease. The purpose of this study is to find out if the investigational drug angiotensin-(1-7) can improve cardiovascular health in people with obesity and high blood pressure.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Hypertension
Full registry criteria
Inclusion Criteria: * Men and women of all races * Age 18 to 65 years * Body mass index (BMI) between 30-45 kg/m2 * Pre-hypertension (defined as two or more seated blood pressure readings \>120/80 mmHg) or hypertension (defined as two or more seated blood pressure readings \>130/80 mmHg or use of antihypertensive medications) * Capable of giving informed consent * Fluent in written and spoken English * Satisfactory history and physical exam Exclusion Criteria: * Age ≤ 17 or ≥ 66 years * Taking more than two antihypertensive medications * Secondary causes of hypertension (e.g., pheochromocytoma, primary aldosteronism, aortic coarctation, adrenal disease) * Pregnant or nursing women * Women taking hormone replacement therapy within 6 months * Decisional impairment * Prisoners * Alcohol or drug abuse * Current smokers * Highly trained athletes * Subjects with \>5% weight change in the past 3 months * BMI \> 45 kg/m2 * Evidence of type I or type II diabetes (fasting glucose \> 126 mg/dL or use of anti-diabetic medications) * History of serious cardiovascular disease (e.g. myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke, transient Ischemic attack) * History or presence of immunological or hematological disorders * Impaired hepatic function \[aspartate aminotransferase (AST) or alanine transaminase (ALT) levels \>2 times upper limit of normal range\] * Impaired renal function (serum creatinine \>2.0 mg/dl) * Anemia * Treatment with drugs increasing sympathetic activity \[e.g., serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors, stimulants\] * Treatment with phosphodiesterase-5 inhibitors * Treatment with anticoagulants (e.g. warfarin) * Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month) * Treatment with any investigational drug in the 1-month preceding the study * Inability to give, or withdraw, informed consent
Primary outcomes
Change in Muscle Sympathetic Nerve Burst Rate120 minutesMuscle sympathetic nerve burst rate will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
Change in Brachial Artery Diameter120 minutesA blood pressure cuff will be inflated to a suprasystolic pressure for 5 minutes then deflated. Brachial artery diameter will be measured continuously before, during, and after cuff inflation using duplex ultrasound at baseline and at the end of angiotensin-(1-7) versus saline infusion.
