The Natriuretic Peptide Response to Saline Infusion

Obesity Clinical Trial

Official title:

The Natriuretic Peptide Response to Saline Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223531
• Other study ID #: 191254
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: June 17, 2022

Study information

• Verified date: January 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt Univeristy	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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