Investigating the effects of angiotensin-(1-7) on energy expenditure in obese individuals

Angiotensin-(1-7) and Energy Expenditure in Human Obesity

This study is testing if a hormone called angiotensin-(1-7) can help obese people burn more energy and improve their metabolism.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT03777215 on ClinicalTrials.gov

What this trial studies

This study aims to explore the role of the hormone angiotensin-(1-7) in regulating energy balance in obese humans. It will involve a randomized, double-blind, two-arm parallel group design where participants will receive either an intravenous infusion of angiotensin-(1-7) or saline. The primary outcome will be the measurement of resting energy expenditure using indirect calorimetry, alongside assessments of blood pressure, heart rate, and metabolic hormone levels. Additionally, biopsies of abdominal white adipose tissue will be taken to analyze gene expression related to thermogenesis. The findings could enhance our understanding of hormonal influences on obesity and energy regulation.

Who should consider this trial

Good fit: Ideal candidates for this study are obese adults aged 18-60 with a BMI between 30-40 kg/m2.

Not a fit: Patients who are under 18 or over 60 years old, pregnant, or have significant cardiovascular or metabolic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic strategies for managing obesity by targeting hormonal pathways to improve energy expenditure.

How similar studies have performed: While the specific approach of targeting angiotensin-(1-7) in humans is novel, similar studies in animal models have shown promising results in understanding its metabolic effects.

Eligibility criteria

Inclusion Criteria:

* Men and women of all races
* Capable of giving informed consent
* Age 18-60 years
* Body mass index (BMI) between 30-40 kg/m2
* Satisfactory history and physical exam

Exclusion Criteria:

* Age ≤ 17 or ≥ 61 years
* Pregnant, nursing, or postmenopausal women
* Decisional impairment
* Prisoners
* Alcohol or drug abuse
* Current smokers
* Highly trained athletes
* Claustrophobia
* Subjects with \>5% weight change in the past 3 months
* Evidence of type I or type II diabetes (fasting glucose \> 126 mg/dL or use of anti-diabetic medications)
* History of serious cardiovascular disease other than hypertension (e.g. myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke, transient Ischemic attack).
* History or presence of immunological or hematological disorders
* Impaired hepatic function (aspartate aminotransferase or alanine aminotransferase levels \>2 times upper limit of normal range)
* Impaired renal function (serum creatinine \>2.0 mg/dl)
* Anemia
* Treatment with anticoagulants (e.g. warfarin)
* Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month)
* Treatment with medications influencing energy expenditure (e.g. psychostimulants)
* Treatment with any investigational drug in the 1-month preceding the study
* Inability to give, or withdraw, informed consent

Where this trial is running

Hershey, Pennsylvania

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Amy C Arnold, PhD — Pennsylvania State University College of Medicine
• Study coordinator: Aimee C Cauffman, BSN

Conditions Obesity