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The Natriuretic Peptide Response to Saline Infusion

The Natriuretic Peptide Response to Saline Infusion

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04223531
Enrollment
18
Registered
2020-01-10
Start date
2020-10-26
Completion date
2022-06-17
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

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

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in circulating levels of proBNP 1-108 from baseline to 6 hoursSaline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours totalproBNP 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 hoursSaline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours totalBNP 1-32 is a hormone made by the heart. The change in circulating levels will be measured in response to saline infusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026