The Natriuretic Peptide Response to Saline Infusion

The primary objective is to evaluate the overarching hypothesis that obese and black individuals have relatively lower circulating natriuretic peptide levels compared with lean and white individuals. Conventional clinical assays for measurement of circulating natriuretic peptides display substantial overlap, precluding determination of the basis of the relative natriuretic peptide deficiency previously observed in these groups. We will study lean or obese, black or white, healthy adult subjects with intravenous (IV) saline infusion as a stimulus for natriuretic peptide production and release. We will measure circulating levels of natriuretic peptide isoforms using mass spectrometry that allows the specific identification of proBNP 1-108 and its cleavage product BNP 1-32.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Normal Saline 0.9% Infusion Solution Bag

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 65 years;
• BMI between 18 and 25 (lean) or 30 and 40 kg/m2 (obese);
• self-reported race of either black or white;
• otherwise healthy with no chronic comorbidities.

Exclusion Criteria:

• History of diabetes mellitus
• Currently pregnant
• History of cardiac disorder including heart failure, cardiomyopathy, myocardial infarction, coronary revascularization, abnormal stress test, uncontrolled arrhythmia or arrhythmia requiring treatment, congenital heart disease, pericardial disease.
• History of hypertension defined as taking anti-hypertensive medications or untreated hypertension with systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg at most recent clinical visit or screening visit.
• Obstructive lung disease
• History of chronic kidney disease
• History of liver disease or cirrhosis
• Uncontrolled thyroid dysfunction
• History of solid organ transplant
• History of malignancy other than basal or squamous cell skin cancer
• Inability to lie flat for 6 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Saline; Each participant will receive a saline infusion of normal saline 0.9%NaCl	Drug: Normal Saline 0.9% Infusion Solution Bag; Participants will receive a normal saline infusion at a rate of 10ml per unit of body surface area per minute for 120 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in circulating levels of proBNP 1-108 from baseline to 6 hours	proBNP 1-108 is a protein made by the heart. The change in circulating levels will be measured in response to saline infusion	Saline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours total
Change in circulating levels of proBNP 1-32 from baseline to 6 hours	BNP 1-32 is a hormone made by the heart. The change in circulating levels will be measured in response to saline infusion	Saline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours total

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Deepak K Gupta, MD, MSCI, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 191254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Only deidentified individual participant data will be provided to interested researchers with a data use agreement and confirmation that no protected health information will be shared, all data will be stored in password protected databases accessible to only key study personnel, and that data will be returned or destroyed after completion or 6 years, whichever is shorter.
• IPD Sharing Time Frame: No later than 1 year after completion of the study.
• IPD Sharing Access Criteria: Only deidentified individual participant data will be provided to interested researchers with a data use agreement and confirmation that no protected health information will be shared, all data will be stored in password protected databases accessible to only key study personnel, and that data will be returned or destroyed after completion or 6 years, whichever is shorter.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No