Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
NCT02646475

Metabolic Effects of Angiotensin-(1-7)

Led by Vanderbilt University · Updated on 2025-05-13

26

Participants Needed

1

Research Sites

721 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with obesity and insulin resistance. The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.

CONDITIONS

Official Title

Metabolic Effects of Angiotensin-(1-7)

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • 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 (fasting glucose >126 mg/dl, use of anti-diabetic medications)
  • Cardiovascular disease other than hypertension such as recent myocardial infarction, angina, arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, heart block, or valve stenosis
  • History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack
  • History or presence of immunological or hematological disorders
  • Impaired liver function (AST or ALT > 2 times upper normal limit)
  • Impaired kidney 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 or norepinephrine transporter 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 preventing completion of the study protocol as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

C

Cynthia Laws, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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