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History of Changes for Study: NCT03777215
Angiotensin-(1-7) and Energy Expenditure in Human Obesity
Latest version (submitted June 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 14, 2018 None (earliest Version on record)
2 December 16, 2018 IPDSharing, Eligibility, Outcome Measures and Study Status
3 February 18, 2019 Study Status
4 April 18, 2019 Outcome Measures, Study Description, Study Status, Study Design and Oversight
5 June 14, 2019 Study Status and Study Design
6 August 8, 2019 Study Status
7 September 27, 2019 Recruitment Status, Study Status and Contacts/Locations
8 November 4, 2019 Study Status
9 January 3, 2020 Study Status
10 April 16, 2020 Study Status
11 June 29, 2020 Study Status
12 October 7, 2020 Study Status
13 February 18, 2021 Study Status
14 August 1, 2021 Study Status
15 December 12, 2021 Study Status
16 June 2, 2022 Study Status
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Study NCT03777215
Submitted Date:  December 14, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 00009895
Brief Title: Angiotensin-(1-7) and Energy Expenditure in Human Obesity
Official Title: Angiotensin-(1-7) and Energy Expenditure in Human Obesity
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2018
Overall Status: Not yet recruiting
Study Start: June 2019
Primary Completion: June 2021 [Anticipated]
Study Completion: June 2022 [Anticipated]
First Submitted: December 12, 2018
First Submitted that
Met QC Criteria:
December 14, 2018
First Posted: December 17, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
December 14, 2018
Last Update Posted: December 17, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Amy Arnold
Responsible Party: Sponsor-Investigator
Investigator: Amy Arnold
Official Title: Assistant Professor
Affiliation: Milton S. Hershey Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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 hypothesis that angiotensin-(1-7) increases energy expenditure and fat tissue heat production (adipose thermogenesis) in human obesity.
Detailed Description: Angiotensin-(1-7) is a beneficial hormone of the renin-angiotensin system known to produce positive cardiovascular and metabolic effects in animal models. In this study, the investigators will determine if angiotensin-(1-7) can increase energy expenditure and promote white adipose tissue heat production (thermogenesis) in obese human subjects. The investigators will perform a randomized, double-blind, two-arm parallel group study to determine effects of acute intravenous angiotensin-(1-7) versus saline infusion on energy expenditure measured by indirect calorimetry in obese human participants. In addition, blood pressure and heart rate will be measured and blood samples obtained to measure for changes in circulating renin-angiotensin system and metabolic hormones. Abdominal subcutaneous white adipose biopsies will also be obtained from obese human participants during acute angiotensin-(1-7) versus saline infusions to examine for changes in gene expression for markers of thermogenesis. The findings from these studies will advance understanding of hormonal mechanisms involved in the etiology of obesity, and provide new insight into the potential for targeting angiotensin-(1-7) to improve energy balance in human obesity.
Open or close this module Conditions
Conditions: Obesity
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Angiotensin-(1-7)
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)
This is a biologically active beneficial hormone of the renin-angiotensin system.
Other Names:
  • Angiotensin I/II (1-7) Acetate
Placebo Comparator: Placebo
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
Saline will be used as the placebo comparator.
Other Names:
  • 0.9% sodium chloride
  • normal saline
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Energy expenditure
[ Time Frame: 120 minutes ]

Change in energy expenditure measured by indirect calorimetry at baseline and at end of angiotensin-(1-7) versus saline infusion.
Secondary Outcome Measures:
1. Uncoupling Protein 1
[ Time Frame: 120 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.
2. Abdominal heat production
[ Time Frame: 1 minute at baseline and end of infusion ]

Change in abdominal heat production will be measured by infrared heat photographs taken at baseline and at end of angiotensin-(1-7) versus saline infusion.
3. Blood pressure
[ Time Frame: 120 minutes ]

Change in arm and finger cuff blood pressure following angiotensin-(1-7) versus saline infusion
4. Angiotensin II
[ Time Frame: 120 minutes ]

Change in circulating levels of angiotensin II measured at baseline and following angiotensin-(1-7) versus saline infusion.
5. Insulin
[ Time Frame: 120 minutes ]

Change in circulating levels of insulin at baseline and following angiotensin-(1-7) versus saline infusion.
6. Angiotensin-(1-7)
[ Time Frame: 120 minutes ]

Change in circulating levels of angiotensin-(1-7) measured at baseline and following angiotensin-(1-7) versus saline infusion.
7. Plasma Renin Activity
[ Time Frame: 120 minutes ]

Change in plasma renin activity measured at baseline and following angiotensin-(1-7) versus saline infusion.
8. Aldosterone
[ Time Frame: 120 minutes ]

Change in circulating levels of aldosterone measured at baseline and following angiotensin-(1-7) versus saline infusion.
9. Glucose
[ Time Frame: 120 minutes ]

Change in circulating levels of glucose measured at baseline and following angiotensin-(1-7) versus saline infusion.
10. Free Fatty Acids
[ Time Frame: 120 minutes ]

Change in circulating levels of free fatty acids measured at baseline and following angiotensin-(1-7) versus saline infusion.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 (AST or ALT 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
Open or close this module Contacts/Locations
Central Contact Person: Aimee C Cauffman, BSN
Telephone: 717-531-1617
Email: acauffman@pennstatehealth.psu.edu
Study Officials: Amy C Arnold, PhD
Principal Investigator
Pennsylvania State University College of Medicine
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
IPD will not be made available to other researchers.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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