The Diurnal Rhythm in Natriuretic Peptide Levels
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| ClinicalTrials.gov Identifier: NCT03834168 |
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Recruitment Status :
Completed
First Posted : February 7, 2019
Results First Posted : August 31, 2021
Last Update Posted : August 31, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Natriuretic Peptides Obesity Nocturnal Blood Pressure | Other: standardized Study Diet | Not Applicable |
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:
- to examine whether there is a presence of a 24-hour rhythm in natriuretic peptide levels among normotensive obese and African-American individuals and whether there is a difference in the rhythmicity of natriuretic peptide levels between obese and lean as well as in African-Americans and whites;
- to examine whether there is an existence of a relationship between 24-hour variability of natriuretic peptide levels and 24-hour patterns of blood pressure and whether this relationship of rhythmicity of natriuretic peptide levels and nocturnal blood pressure differed in obese and lean individuals and by race.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | The Diurnal Rhythm in Natriuretic Peptide Levels and Relationship With Nocturnal Blood Pressure |
| Actual Study Start Date : | April 1, 2019 |
| Actual Primary Completion Date : | March 31, 2021 |
| Actual Study Completion Date : | March 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Study Individuals
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).
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Other: standardized Study Diet
Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days. |
- Plasma MRproANP [ Time Frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days ]Assess the diurnal rhythm in circulating MRproANP levels among obese individuals and compared it with lean individuals
- Acrophase Difference in Hours Between the MR-proANP and Systolic BP Rhythm [ Time Frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days ]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
- Plasma MRproANP [ Time Frame: About 24 hours on the in-patient study visit day after consuming study meals for 5 days ]Assess the diurnal rhythm in circulating MRproANP levels among African-American individuals and compared it with white individuals
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834168
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Pankaj Arora, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Orlando M Gutierrez, MMSc | University of Alabama at Birmingham |
Documents provided by Pankaj Arora, MD, University of Alabama at Birmingham:
Other Publications:
| Responsible Party: | Pankaj Arora, MD, Assistant Professor, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT03834168 |
| Other Study ID Numbers: |
IRB-300002114 |
| First Posted: | February 7, 2019 Key Record Dates |
| Results First Posted: | August 31, 2021 |
| Last Update Posted: | August 31, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Diurnal Rhythm Race |