Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
26 (estimated)
Sponsor
Vanderbilt University · Other
Who this trial is looking for
This trial is looking for adults with obesity and insulin resistance. Participants will receive an infusion of a substance called angiotensin-(1-7) to see if it helps improve their body's response to insulin and affects blood pressure.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetesSignificant heart disease
You may be able to join if
I am between 18 and 60 years old
I have a body mass index between 30 and 40
I have insulin resistance
I have high blood pressure or take blood pressure medication
I can provide informed consent
You may not be able to join if
I am pregnant or breastfeeding
I smoke or have a history of heavy smoking
I have a history of alcohol or drug abuse
I have a body mass index over 40
I have diabetes or take diabetes medication
I have a serious heart condition
I have had a stroke or transient ischemic attack
I have certain blood disorders or liver problems
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 measur…
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)
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