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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Univeristy

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline 0.9% Infusion Solution Bag

Drug

Participants will receive a normal saline infusion at a rate of 10ml per unit of body surface area per minute for 120 minutes.

Primary outcomes

Change in circulating levels of proBNP 1-108 from baseline to 6 hours

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jan 10, 2020
Registry last updated: Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed