Effects of angiotensin-(1-7) on metabolism in obese individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the metabolic effects of angiotensin-(1-7) in individuals with obesity and insulin resistance. Participants will undergo two outpatient visits where they will receive either an intravenous infusion of angiotensin-(1-7) or saline. The study aims to measure changes in insulin sensitivity, blood pressure, and related hormonal responses using hyperinsulinemic-euglycemic clamp methods and other assessments. The goal is to determine if angiotensin-(1-7) can improve metabolic function in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Alfredo Gamboa, MD — Vanderbilt University Medical Center
• Study coordinator: Cynthia Laws, MS
• Email: cynthia.laws@vumc.org
• Phone: 615-421-1994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.