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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.
Obese and African-American individuals are at greater risk for cardiovascular morbidity and mortality than lean and white individuals. One of the key reasons for this health disparity is a higher risk of hypertension among obese and African-American individuals. The reasons for why these disparities develop are not well understood.
Natriuretic peptides are hormones produced by the heart and have a wide range of favorable cardiovascular effects such as natriuresis (sodium excretion), vasodilation, and direct inhibition of the renin-angiotensin-aldosterone system. Human studies showed the existence of 24-hour (diurnal) variations in the circulating natriuretic peptide levels.
Prior work from the investigators and others demonstrated that individuals with genetically-determined lower circulating natriuretic peptides levels have higher blood pressure and greater risk of hypertension. Further, the investigators have shown that obesity and African-American race are associated with lower natriuretic peptide levels, suggesting that relatively low natriuretic peptide levels may be a biologic determinant contributing to health disparities.
Obese and African-American individuals have a greater prevalence of nocturnal hypertension [nighttime blood pressure >120/80 mmHg], which is an independent risk factor for cardiovascular events. The underlying reasons for 24-hour variations in blood pressure are unknown.
The investigators hypothesize that loss of the natural 24-hour rhythm of natriuretic peptide levels plays a role in the development of nocturnal hypertension in obese and African-American individuals. The aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standardized Study Diet | Other | Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pankaj Arora, MD | University of Alabama at Birmingham | Principal Investigator |
| Orlando M Gutierrez, MMSc | 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 |
|---|---|---|---|
| 22282468 | Background | 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. | |
| 25595796 | 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. |
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A total of 42 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had one study dropout and one participant was not able to complete the protocol. A total of 40 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lean | Healthy self-identified African-American and white male lean 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
| FG001 | Obese | Healthy self-identified African-American and white male obese 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lean | Healthy self-identified African-American and white lean 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals | Posted | Median | Inter-Quartile Range | pmol/l | About 24 hours on the in-patient study visit day after consuming study meals for 5 days |
|
1 month
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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 | Lean | Healthy self-identified African-American and white lean 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pankaj Arora | UNIVERSITY OF ALABAMA AT BIRMINGHAM | 2059754720 | 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_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2021 | May 28, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 29167879 | 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. |
| 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. |
| 33958126 | Result | 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. |
| BG001 | Obese | Healthy self-identified African-American and white obese 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Hip circumference | Median | Inter-Quartile Range | cm |
|
| Waist circumference | Median | Inter-Quartile Range | cm |
|
| Systolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Diastolic Blood Pressure | Median | Inter-Quartile Range | mmHg |
|
| Heart rate | Median | Inter-Quartile Range | beats/min |
|
| Fasting Glucose | Median | Inter-Quartile Range | mg/dL |
|
| Renal Function | Median | Inter-Quartile Range | mg/dL |
|
| Serum Electrolytes | Median | Inter-Quartile Range | mEq/L |
|
| Serum Calcium | Median | Inter-Quartile Range | mg/dL |
|
| Liver Function | Median | Inter-Quartile Range | mg/dL |
|
| Hematological Parameters | Median | Inter-Quartile Range | cells*10,000/mm^3 |
|
| Hemoglobin | Median | Inter-Quartile Range | g/dL |
|
| Hematocrit | Median | Inter-Quartile Range | % |
|
| Mean Corpuscular Volume (MCV) | Median | Inter-Quartile Range | fl |
|
| Mean Corpuscular Hemoglobin (MCH) | Median | Inter-Quartile Range | pg |
|
| Mean Corpuscular Hemoglobin Concentration (MCHC) | Median | Inter-Quartile Range | g/dL |
|
| Red Cell Distribution Width (RDW) | Median | Inter-Quartile Range | % |
|
| Mean Platelet Volume (MPV) | Median | Inter-Quartile Range | fL |
|
| OG001 | Obese | Healthy self-identified African-American and white obese 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day 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 | Posted | Mean | Standard Error | Hours | About 24 hours on the in-patient study visit day after consuming study meals for 5 days |
|
|
|
| Other Pre-specified | Plasma MRproANP | Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals | The race-specific analysis was not done for this study | Posted | About 24 hours on the in-patient study visit day after consuming study meals for 5 days |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Obese | Healthy self-identified African-American and white obese 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). standardized Study Diet: Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |