Effects of angiotensin-(1-7) on metabolism in obese individuals
Metabolic Effects of Angiotensin-(1-7)
This study is testing if a substance called angiotensin-(1-7) can help improve metabolism and insulin sensitivity in people who are obese and have insulin resistance.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT02646475 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic effects of angiotensin-(1-7) in individuals with obesity and insulin resistance. Participants will undergo two outpatient visits where they will receive either an intravenous infusion of angiotensin-(1-7) or saline. The study aims to measure changes in insulin sensitivity, blood pressure, and related hormonal responses using hyperinsulinemic-euglycemic clamp methods and other assessments. The goal is to determine if angiotensin-(1-7) can improve metabolic function in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with obesity (BMI 30-40 kg/m2) and insulin resistance.
Not a fit: Patients with type I or type II diabetes, morbid obesity, or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments for obesity and insulin resistance, potentially improving metabolic health.
How similar studies have performed: While the effects of angiotensin-(1-7) have been studied in animal models, this approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Alfredo Gamboa, MD — Vanderbilt University Medical Center
- Study coordinator: Cynthia Laws, MS
- Email: cynthia.laws@vumc.org
- Phone: 615-421-1994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.