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

NCT03777215 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 9895
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Resting energy expenditure

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

  120 minutes

• Uncoupling protein 1

  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.

  120 minutes

Secondary Outcomes (2)

• Blood pressure

  120 minutes

• Heart rate

  120 minutes

Other Outcomes (11)

• Skin temperature

  120 minutes

• Skin blood flow

  120 minutes

• Abdominal heat production

  120 minutes

Study Arms (2)

Angiotensin-(1-7)

EXPERIMENTAL

Subjects will receive intravenous infusion of three ascending doses of angiotensin-(1-7). The doses are: 2, 4, and 8 ng/kg/min. Each dose will be maintained for 10 minutes, with the highest dose maintained for an additional 90 minutes. The total infusion period is 120 minutes.

Drug: Angiotensin-(1-7)

Placebo

PLACEBO COMPARATOR

Subjects will receive intravenous infusion of saline that is matched in volume to the angiotensin-(1-7). The total infusion period is 120 minutes.

Drug: Saline

Interventions

Angiotensin-(1-7) DRUG

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

Also known as: Angiotensin I/II (1-7) Acetate

Angiotensin-(1-7)

Saline DRUG

Saline will be used as the placebo comparator.

Also known as: 0.9% sodium chloride, normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amy Arnold: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

angiotensin I (1-7); Acetates; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Amy C Arnold, PhD

  Pennsylvania State University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 17, 2018
• Study Start: September 26, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)