Clinical trial

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

Active, not recruiting · Early Phase 1 · 1 countries · Registry ID NCT03777215

Active, not recruitingEarly Phase 1Interventional

What this study is about

The objective of this study is to better define the role of the hormone angiotensin-(1-7) in energy balance. We will test the overall hypothesis that angiotensin-(1-7) increases resting energy expenditure and promotes markers of heat production (thermogenesis) in white adipose tissue in human obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

Angiotensin-(1-7)

Drug

This is a biologically active beneficial hormone of the renin-angiotensin system.

Saline

Drug

Saline will be used as the placebo comparator.

Primary outcomes

Resting energy expenditure120 minutes

Change in resting energy expenditure measured by indirect calorimetry at baseline and at end of angiotensin-(1-7) versus saline infusion.

Uncoupling protein 1120 minutes

White adipose tissue biopsies will be taken at end of angiotensin-(1-7) versus saline infusion to assess gene expression of the heat producing (thermogenic) marker uncoupling protein 1.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Penn State Milton S. Hershey Medical Center🇺🇸 Hershey, Pennsylvania, United States