The Natriuretic Peptide Response to Saline Infusion

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Normal Saline 0.9% Infusion Solution Bag

• Registration Number: NCT04223531
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2020-10-26
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saline	Normal Saline 0.9% Infusion Solution Bag	Each participant will receive a saline infusion of normal saline 0.9%NaCl

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt Univeristy; 🇺🇸 Nashville, Tennessee, United States