The Natriuretic Peptide Response to Saline Infusion

NCT04223531 | Completed

• 1 other identifier: 191254
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  proBNP 1-108 is a protein made by the heart. The change in circulating levels will be measured in response to saline infusion

  Saline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours total

• Change in circulating levels of proBNP 1-32 from baseline to 6 hours

  BNP 1-32 is a hormone made by the heart. The change in circulating levels will be measured in response to saline infusion

  Saline infusion will be given for 2 hours (with 4 hour observation) with blood samples collected at hourly intervals for 7 hours total

Study Arms (1)

Saline

OTHER

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

Drug: Normal Saline 0.9% Infusion Solution Bag

Interventions

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.

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Univeristy

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Deepak K Gupta, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: January 10, 2020
• Study Start: October 26, 2020
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: No later than 1 year after completion of the study.
• Access Criteria: Only deidentified individual participant data will be provided to interested researchers with a data use agreement and confirmation that no protected health information will be shared, all data will be stored in password protected databases accessible to only key study personnel, and that data will be returned or destroyed after completion or 6 years, whichever is shorter.

Locations

US (1)