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/33958126Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05216042
Atrial Natriuretic Peptide and Regulation of Cardiometabolic Health: A Genotype-Guided Human Physiological Study
Led by University of Alabama at Birmingham · Updated on 2026-04-09
200
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Equal number of males and females
- Consent to genetic material collection
- Willingness to follow the study protocol
You will not qualify if you...
- Age under 18 years at screening
- Body mass index greater than 45 kg/m2
- Blood pressure higher than 140/90 mmHg
- Taking more than 2 hypertension medications
- History of diabetes or fasting blood sugar over 126 mg/dl or HbA1C of 6.5% or higher or prior antidiabetic treatment
- Past or current cardiovascular diseases such as stroke, seizure, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia
- Pregnant or breastfeeding women or those who can become pregnant and are not using reliable birth control
- Estimated kidney function (GFR) below 60 ml/min/1.73 m2 or albumin creatinine ratio 30 mg/g or higher
- Liver enzyme levels more than three times the normal limit
- Anemia (men with hematocrit below 38%, women below 36%)
- Inability to exercise on a treadmill
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
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
Study Diet
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
Exercise Challenge
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
Glucose Challenge
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
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Loading map...
Research Team
N
Nehal Vekariya, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Acute Metabolic Influences on the Natriuretic Peptide System in Humans.
Pankaj Arora, Connie Wu, Tariq Hamid...
https://pubmed.ncbi.nlm.nih.gov/26892417Racial 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.
Navkaranbir S Bajaj, Orlando M Gutiérrez, Garima Arora...
https://pubmed.ncbi.nlm.nih.gov/29167879Weight loss, saline loading, and the natriuretic peptide system.
Pankaj Arora, Jason Reingold, Aaron Baggish...
https://pubmed.ncbi.nlm.nih.gov/25595796Nocturnal blood pressure dipping in treated hypertensives: insights from the SPRINT trial.
Vibhu Parcha, Rajat Kalra, Peng Li...
https://pubmed.ncbi.nlm.nih.gov/33624057