The Natriuretic Peptide Response to Saline Infusion

NCT ID: NCT04223531

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-06-17

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Saline

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

Group Type: OTHER

Normal Saline 0.9% Infusion Solution Bag

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Deepak Gupta

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepak K Gupta, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Univeristy

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

191254

Identifier Type: -

Identifier Source: org_study_id