Obesity Clinical Trial
Official title:
The Diurnal Rhythm in Natriuretic Peptide Levels and Relationship With Nocturnal Blood Pressure
Verified date | January 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | March 31, 2021 |
Est. primary completion date | February 29, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plasma MRproANP | Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals | About 24 hours on the in-patient study visit day after consuming study meals for 5 days | |
Primary | 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 | Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm | Assess relationship between 24-hour variability of MRproANP levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of MRproANP levels and nocturnal blood pressure differed in obese and lean individuals and by race | About 24 hours on the in-patient study visit day after consuming study meals for 5 days |
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