The Natriuretic Peptide Response to Saline Infusion

Vanderbilt University Medical Center

Status: Completed

Conditions: Obesity

Treatments: Drug: Normal Saline 0.9% Infusion Solution Bag

Study type: Interventional

Funder types: Other

Identifiers

NCT04223531

191254

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Saline

Other group

Description:

Each participant will receive a saline infusion of normal saline 0.9%NaCl

Treatment:

Drug: Normal Saline 0.9% Infusion Solution Bag