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The purpose of the study is to discover any racial dissimilarity in the response of Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate challenge
Previous studies have shown an association between reduced levels of circulating natriuretic peptides (NPs) and obesity in humans. This association is especially pronounced in those with metabolic syndrome traits and elevated plasma insulin. As previously conducted study has shown that an increase in NPs with weight loss in obese individuals is "primary" and not secondary to alteration in cardiac structure or function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African-American | Experimental | 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. |
|
| White | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study diet | Dietary Supplement | Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma MRproANP | Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI) | From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Circulating Plasma MRproANP | Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI) | From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pankaj Arora, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26892417 | 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. | |
| 25595796 | Background |
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A total of 81 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had 7 study dropouts and 2 participants were not able to complete the protocol. A total of 72 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 the 4th day, participants will come to the clinic in a 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 a 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 the next 8 hours. |
| FG001 | 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 the 4th day, participants will come to the clinic in a 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 a 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 the next 8 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma MRproANP | Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI) | Posted | Mean | 95% Confidence Interval | Percentage of change | From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 the 4th day, participants will come to the clinic in a 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 a 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 the next 8 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pankaj Arora | UNIVERSITY OF ALABAMA AT BIRMINGHAM | 12059754720 | parora@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2021 | May 28, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2019 | Oct 4, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Each participant will be enrolled into one of the two groups by race.
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| Glucose Challenge | Other | 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. |
|
| Serum Insulin | The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites | At 1 hour after glucose challenge |
| Serum Glucose | The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites | At 1 hour after glucose challenge |
| Plasma NTproBNP | Change in circulating NTproBNP levels in response to glucose challenge in African-Americans and Whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log NTproBNP with 95% CI) | From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days |
| Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites | The relative circulating Neprilysin (Membrane Metalloendopeptidase) mRNA quantification (fold change) at baseline between African-Americans and Whites | At baseline |
| 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. |
| 27185878 | Background | 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. |
| 31588864 | Result | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
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| Systolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
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| Sodium | Median | Inter-Quartile Range | mmol/L |
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| Potassium | Median | Inter-Quartile Range | mmol/L |
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| Creatinine | Median | Inter-Quartile Range | mmol/L |
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| Percentage of Hematocrit | Median | Inter-Quartile Range | % |
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| Fasting Glucose | Mean | Standard Deviation | mg/dL |
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| Fasting Insulin | Mean | Standard Deviation | mg/dL |
|
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR is used to estimate insulin resistance. HOMA-IR = Fasting insulin levels in mU/l X Fasting glucose levels in mg/dl/405. The normal HOMA-IR value in healthy humans ranges from 0.5-1.4. The HOMA-IR value greater than 2.5 indicates significant insulin resistance. The HOMA-IR above 1.9 indicates early insulin resistance. | Mean | Standard Deviation | Ratio |
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| Mid-regional pro-atrial natriuretic peptide (MRproANP) | Median | Inter-Quartile Range | pmol/L |
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| B-type natriuretic peptide (BNP) | Median | Inter-Quartile Range | pg/mL |
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| N-terminal pro-B-type natriuretic peptide (NTproBNP) | Median | Inter-Quartile Range | pg/mL |
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| Secondary | The Difference in Circulating Plasma MRproANP | Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI) | Posted | Mean | 95% Confidence Interval | Percentage change | From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days |
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| Secondary | Serum Insulin | The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites | Posted | Mean | Standard Deviation | µU/mL | At 1 hour after glucose challenge |
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| Secondary | Serum Glucose | The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites | Posted | Mean | Standard Error | mg/dL | At 1 hour after glucose challenge |
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| Secondary | Plasma NTproBNP | Change in circulating NTproBNP levels in response to glucose challenge in African-Americans and Whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log NTproBNP with 95% CI) | Posted | Mean | Standard Error | Percentage | From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days |
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| Secondary | Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites | The relative circulating Neprilysin (Membrane Metalloendopeptidase) mRNA quantification (fold change) at baseline between African-Americans and Whites | Posted | Mean | Standard Error | fold change | At baseline |
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| 34 |
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| 34 |
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| 34 |
| EG001 | 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 the 4th day, participants will come to the clinic in a 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 a 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 the next 8 hours. | 0 | 38 | 0 | 38 | 0 | 38 |
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| D009750 |
| Nutritional and Metabolic Diseases |