Chronobiology of Natriuretic Peptides and Blood Pressure in Lean and Obese Individuals.
Vibhu Parcha, Nirav Patel, Orlando M Gutierrez...
https://pubmed.ncbi.nlm.nih.gov/33958126/Actively Recruiting
Led by University of Alabama at Birmingham · Updated on 2026-04-09
200
Participants Needed
1
Research Sites
30 weeks
Total Duration
Researchers are studying how genetic differences in natriuretic peptide NP levels affect heart and metabolic health, particularly focusing on people with low levels of these heart-produced hormones. Low NP levels are linked to a higher risk of diabetes and heart problems, especially among obese and Black individuals. This study aims to understand how people with a common genetic variation causing lower NP levels respond to exercise and glucose challenges to improve cardiometabolic health. The study involves two groups of healthy adults classified by their NP genotype one group with low NP genotype and one with high NP genotype. Participants will follow a special diet for five days, then undergo an exercise challenge where they walk on a treadmill at 70% of their maximal oxygen capacity. On the sixth day, after fasting, they will drink a glucose solution and have blood collected every hour for eight hours. These procedures will measure changes in NP and miR-425 levels, energy expenditure, and glucose metabolism. Participants will undergo physical exams and screening to confirm eligibility. Assessments include treadmill exercise tests, DEXA scans to measure body mass, resting energy expenditure tests, and frequent blood sampling after challenges. Researchers will track hormone levels, metabolic changes, and gene expression to evaluate cardiometabolic responses. The study will monitor participants throughout the treatment period and is expected to continue until April 2027.
CONDITIONS
GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study
N
Nehal Vekariya, MS
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University of Alabama at Birmingham
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Low NP Genotype Group | High NP Genotype Group |
|---|---|---|
| What it is | Participants with a genetically determined low natriuretic peptide (NP) profile who receive a fully standardized diet, then undergo exercise and oral glucose challenges with serial metabolic and peptide measurements. | Participants with a genetically determined high natriuretic peptide (NP) profile who follow the same standardized diet, exercise, and oral glucose challenge protocols, with comparable physiological testing. |
| Role in the study | Mechanistic comparator arm—insight into metabolic and cardiovascular responses in low NP genotype individuals under controlled dietary and physiological challenge. | Reference mechanistic arm—serves as the genotype-based comparison group for evaluating physiologic responses in high NP genotype individuals. |
| Primary use or scientific purpose | To assess how a genetically lower natriuretic peptide profile influences the physiological and metabolic response (including natriuretic peptides, glucose, insulin, energy expenditure, and related biomarkers) during standardized diet, exercise, and glucose challenge. | To serve as the comparison for the low NP genotype group, establishing reference values for the same physiological and metabolic endpoints in participants with a high NP genotype in response to identical challenges. |
| How the interventions are performed | Participants consume a controlled study diet for 5 days, undergo VO2 max determination, then complete both an exercise challenge (70% VO2max treadmill for 20 minutes) and an oral glucose challenge (75g glucose, serial blood testing for 8 hours), with measurements of physiologic, metabolic, and hormonal markers. | Procedures are identical: standardized 5-day diet, VO2 max test, then exercise and glucose challenges with matched physiological and metabolic testing intervals. |
| Current evidence in this population | Ongoing mechanistic investigation; published studies show natriuretic peptide hormones influence glucose metabolism and energy balance, but direct physiological differences by genotype in response to controlled dietary and challenge protocols are being evaluated. | Reference group for new mechanistic research; external studies indicate that individuals with higher natriuretic peptide activity have favorable metabolic profiles, but genotype-driven responses under standardized challenge have not been fully characterized. |
| Relevant limitations | Designed as a mechanistic study with moderate sample size, focused on a select and screened population without diabetes or established cardiovascular disease. Findings may not directly generalize to broader or clinical populations; impact on long-term health outcomes remains unestablished. | As a comparison group determined by genotype, this cohort’s findings are limited by the same factors: selectivity of enrollment, lack of randomization, and a research setting that may not mirror everyday clinical care. Results are intended for scientific understanding rather than immediate clinical application. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for physical exam and screening tests
Duration - 5 days
Participants will consume a study diet provided by the clinical research unit's metabolic kitchen for 5 days.
Daily visits or meal pickups for 5 days
Duration - 1 day
Participants will undergo an exercise challenge by walking at 70% of their VO2max for 20 minutes on a treadmill and will also have a resting energy expenditure test.
1 visit (in-person) on the 5th day after diet
Duration - 1 day
Participants will come in fasting state, consume a 75 gm oral glucose solution, followed by blood collection every hour for the next 8 hours to assess metabolic responses.
1 visit (in-person) on the 6th day after diet, with blood collection hourly for 8 hours
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor