NCT02646475RecruitingPhase 1
Metabolic Effects of Angiotensin-(1-7)
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 31 Dec 2015
- Start date
- Feb 2016
- Primary completion date
- Dec 2029
- Lead sponsor
- Vanderbilt University
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT02646475
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 26
- From Feb 2016 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allergic reaction to study 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
- 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
Other illness
- Current smokers or history of heavy smoking (\>2 packs/day)
- History of alcohol or drug abuse
- History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- History or presence of immunological or hematological disorders
Lab values
- Evidence of type I or type II diabetes (i.e. fasting glucose \>126 mg/dl, use of anti-diabetic medications)
- 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)
- 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)
Other
- Pregnancy or breast-feeding
- Morbid obesity (BMI \> 40 kg/m2)
- Inability to give, or withdraw, informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.