Metabolic Effects of Angiotensin-(1-7)

Launched by VANDERBILT UNIVERSITY · Dec 31, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a substance called angiotensin-(1-7) on people who are dealing with obesity and insulin resistance. Insulin resistance happens when the body doesn't respond well to insulin, which can lead to health issues like obesity, high blood pressure, and type II diabetes. Researchers want to see if giving angiotensin-(1-7) through an infusion can help improve how well the body uses insulin and check for any changes in blood pressure and other related health markers.

To participate in this study, you need to be between 18 and 60 years old and have a body mass index (BMI) of 30-40, which means you are classified as obese. You should also have signs of insulin resistance and high blood pressure. However, if you are pregnant, a heavy smoker, or have certain health conditions like diabetes or serious heart issues, you may not qualify. If you decide to join, you’ll receive the treatment and undergo evaluations to see how your body responds. This could help researchers learn more about potential treatments for metabolic diseases in the future.

Gender

ALL

Eligibility criteria

• 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 cutoff will allow us to include subjects with pre-hypertension.
• • Able and willing to provide informed consent
• 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 of anti-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, or transient ischemic attack
• • History or presence of immunological or hematological disorders
• • 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)
• • Anemia (hemoglobin \<13.5 g/dl in males or \<12.5 g/dl in females)
• • Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors
• • Treatment with phosphodiesterase 5 inhibitors
• • Treatment with anticoagulants
• • Treatment with chronic systemic glucocorticoid therapy (more than 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
• • Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol)