Racial Differences in the Natriuretic Peptide Response to Glucose Challenge
NCT ID: NCT03072602
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2017-03-01
2018-10-01
Brief Summary
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Detailed Description
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Previous experimental data suggests that Atrial NP (ANP) has a wide range of favorable metabolic effects including that activation of brown fat and improvement in skeletal muscle oxidative capacity and glucose utilization. New evidence suggests that ANP activation directly modulates insulin sensitivity and energy homeostasis, suggesting that ANP suppression could promote more obesity/insulin resistance. Moreover, ANP exerts potent lipolytic effects in vitro and in vivo. The previous study has shown that a high-carbohydrate challenge in healthy volunteers is associated with a reduction in N-terminal-proANP (NTproANP) but not N-terminal-proB-type NP (NTproBNP) levels. Nonetheless our outcomes were predominantly in Caucasians and warrants replication in other racial groups.
There is no data on the ANP response to high-carbohydrate challenge in African Americans, a racial group with disproportionately greater rates of obesity, insulin resistance, and diabetes as compared to Caucasians. So the investigators have proposed to conduct a pilot study in otherwise healthy, normotensive subjects to examine NP system, especially the effects on MRproANP in response of high-carbohydrate challenge.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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African-American
Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.
Study diet
Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Glucose Challenge
Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
White
Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.
Study diet
Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Glucose Challenge
Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Interventions
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Study diet
Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Glucose Challenge
Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Eligibility Criteria
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Inclusion Criteria
* Blood pressure less than 140/90
* Estimated creatinine clearance \>60cc/min
* Willingness to comply with the study diet
Exclusion Criteria
* 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% in men and \<35% in women
* Abnormal serum sodium or potassium
* Urine β-HCG consistent with pregnancy
* Abnormal liver function tests (\>3x upper limit of normal)
* Women taking hormonal birth control
* Current smokers
* Regular users of non-steroid anti-inflammatory medications
18 Years
40 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Pankaj Arora, MD
Assistant Professor
Principal Investigators
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Pankaj Arora, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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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.
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.
Wu C, Arora P, Agha O, Hurst LA, Allen K, Nathan DI, Hu D, Jiramongkolchai P, Smith JG, Melander O, Trenson S, Janssens SP, Domian I, Wang TJ, Bloch KD, Buys ES, Bloch DB, Newton-Cheh C. Novel MicroRNA Regulators of Atrial Natriuretic Peptide Production. Mol Cell Biol. 2016 Jun 29;36(14):1977-87. doi: 10.1128/MCB.01114-15. Print 2016 Jul 15.
Patel N, Russell GK, Musunuru K, Gutierrez OM, Halade G, Kain V, Lv W, Prabhu SD, Margulies KB, Cappola TP, Arora G, Wang TJ, Arora P. Race, Natriuretic Peptides, and High-Carbohydrate Challenge: A Clinical Trial. Circ Res. 2019 Nov 8;125(11):957-968. doi: 10.1161/CIRCRESAHA.119.315026. Epub 2019 Oct 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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X16081002
Identifier Type: -
Identifier Source: org_study_id
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