RECRUITING

Metabolic Effects of Angiotensin-(1-7)

Conditions

Obesity Insulin Resistance Hypertension Metabolic Cardiovascular Syndrome renin-angiotensin system angiotensin blood pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Metabolic Effects of Angiotensin-(1-7)

Quick Facts

Study Start:2016-02

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02646475

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Kaleigh Rae, MPH

CONTACT

615-875-7421

kaleigh.rae@vanderbilt.edu

Principal Investigator

Italo Biaggioni, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University

Study Locations (Sites)

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University

Italo Biaggioni, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-02

Study Completion Date2026-12

Study Record Updates

Study Start Date2016-02

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

renin-angiotensin system
angiotensin
insulin resistance
blood pressure

Additional Relevant MeSH Terms

Obesity
Insulin Resistance
Hypertension
Metabolic Cardiovascular Syndrome