Metabolic Effects of Angiotensin-(1-7) in Obesity and Insulin Resistance

This study is investigating how a substance called Angiotensin-(1-7) affects metabolism in people with obesity and insulin resistance (when your body's cells don't respond well to insulin). Researchers want to see if Angiotensin-(1-7) can improve how well your body uses insulin. You may be able to join if you are between 18 and 60 years old, have obesity (BMI between 30-40 kg/m2), insulin resistance (HOMA2-IR score >2.2), and high blood pressure. The main goal is to measure changes in your body's insulin sensitivity. The study is currently unclear on its recruitment status and plans to enroll 26 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 26 participants. Participants will receive either Angiotensin-(1-7) or a saline placebo.
What's involved
You will have a screening visit and two study days at the Vanderbilt Clinical Research Center. Each study day lasts about four hours and involves intravenous catheters, blood pressure cuffs, heart rate monitoring, blood samples, and a rebreathing test.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT02646475

Metabolic Effects of Angiotensin-(1-7)

Recruiting
PHASE1Ages 18–60Interventional
Vanderbilt University
~26 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Angiotensin-(1-7)Saline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Whole-Body Insulin Sensitivity
Measured over steady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp
Obesity
Insulin Resistance
Hypertension
Metabolic Cardiovascular Syndrome
1 sites across 1 states
Tennessee1
  • Alfredo Gamboa, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Eligibility criteria

Inclusion

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

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)
  • Whole-Body Insulin Sensitivitysteady-state (time 90 to 120 minutes) during hyperinsulinemic-euglycemic clamp

    Whole-body insulin sensitivity will be defined as the glucose infusion rate needed to maintain euglycemia during steady state (time=90 to 120 minutes) of the hyperinsulinemic-euglycemic clamp following angiotensin-(1-7) versus saline infusion. The insulin sensitivity will be corrected by body weight, lean body mass, and steady-state plasma insulin concentrations.