The Diurnal Rhythm in Natriuretic Peptide Levels

NCT03834168 | Completed Results

• 1 other identifier: IRB-300002114
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study to assess the diurnal rhythm in natriuretic peptide levels and its temporal relationship with nocturnal blood pressure in obese and African-American individuals as compared with lean and white individuals.

Conditions

Natriuretic Peptides; Obesity; Nocturnal Blood Pressure

Keywords

Diurnal Rhythm; Race

Outcome Measures

Primary Outcomes (1)

• Plasma MRproANP

  Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals

  About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Secondary Outcomes (1)

• Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm

  About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Other Outcomes (1)

• Plasma MRproANP

  About 24 hours on the in-patient study visit day after consuming study meals for 5 days

Study Arms (1)

Study Individuals

OTHER

Healthy self-identified African-American and white male participants will be screened. Study consent will be obtained, medical history and physical examination administered, and study eligibility determined based on the inclusion and exclusion criteria. Eligible subjects will meet a bio-nutritionist who will explain the 5 days of standardized diet at the screening visit and will review instructions for complying with the diet. If the subject agrees to adhere to the study diet, they will then be enrolled in the study (stratified by race).

Other: standardized Study Diet

Interventions

standardized Study Diet OTHER

Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.

Study Individuals

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 40 years
• Blood pressure less than 140/90
• Body Mass Index between 18.5 to 25 kg/m2 (lean) or 30 to 45 kg/m2 (obese)
• Self identified African-American or white individuals
• Willingness to comply with the study diet
• Provide informed consent

You may not qualify if:

• History of hypertension
• History of cardiovascular, renal, or liver disease
• Diabetes or use of glucose-lowering medications
• Use of vasoactive or diuretic medications
• Atrial fibrillation
• Anemia (Hematocrit \<41%)
• Abnormal serum sodium or potassium
• Abnormal liver function tests (\>3x upper limit of normal)
• Current smokers
• Regular users of non-steroid anti-inflammatory medications

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (5)

• Goetze JP, Jorgensen HL, Sennels HP, Fahrenkrug J. Diurnal plasma concentrations of natriuretic propeptides in healthy young males. Clin Chem. 2012 Apr;58(4):789-92. doi: 10.1373/clinchem.2011.178921. Epub 2012 Jan 26. No abstract available.

  PMID: 22282468 BACKGROUND

• Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.

  PMID: 25595796 BACKGROUND

• Bajaj NS, Gutierrez OM, Arora G, Judd SE, Patel N, Bennett A, Prabhu SD, Howard G, Howard VJ, Cushman M, Arora P. Racial Differences in Plasma Levels of N-Terminal Pro-B-Type Natriuretic Peptide and Outcomes: The Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study. JAMA Cardiol. 2018 Jan 1;3(1):11-17. doi: 10.1001/jamacardio.2017.4207.

  PMID: 29167879 BACKGROUND

• Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.

  PMID: 26892417 BACKGROUND

• Parcha V, Patel N, Gutierrez OM, Li P, Gamble KL, Musunuru K, Margulies KB, Cappola TP, Wang TJ, Arora G, Arora P. Chronobiology of Natriuretic Peptides and Blood Pressure in Lean and Obese Individuals. J Am Coll Cardiol. 2021 May 11;77(18):2291-2303. doi: 10.1016/j.jacc.2021.03.291.

  PMID: 33958126 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Pankaj Arora
• Organization: UNIVERSITY OF ALABAMA AT BIRMINGHAM

parora@uabmc.edu

2059754720

Study Officials

• Pankaj Arora, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Orlando M Gutierrez, MMSc

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: April 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: March 31, 2021
• Last Updated: February 5, 2024
• Results First Posted: August 31, 2021

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)