NCT05216042 · University of Alabama at Birmingham
GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study
What this study is about
Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health.
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Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have \~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have \~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them.
Interventions
DIETARY_SUPPLEMENT
Study diet
Participants will consume the study diet for 5 days provided by the clinical research unit's metabolic kitchen (at UAB)
OTHER
Exercise capacity VO2 max determination
Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol and will also undergo a DEXA scan to determine the body mass.
OTHER
Exercise Challenge
Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill and will also undergo a resting energy expenditure test.
OTHER
Glucose Challenge
Participants will come in fasting state on day 6th and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
Primary outcome measures
Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group.
Time frame: From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days
Change in Exercise Energy Expenditure between the high genotype and low genotype group.
Time frame: About 3 hours on the exercise challenge visit day after consuming study meals for 4 days
Change in miR-425 levels following a standardized oral glucose challenge in those with low ANP genotype.
Time frame: From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days
Change in miR-425 levels following a standardized exercise challenge in those with low ANP genotype.
Time frame: About 3 hours on the exercise challenge visit day after consuming study meals for 4 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults: Age more than or equal to 18; an equal number of Males and Females
- Consent to the collection of genetic material
- Willing to adhere to the study protocol
Exclusion criteria
- Age \<18, at screening.
- BMI \>45 kg/m2.
- Blood pressure more than 140/90 mmHg.
- Participants who are taking more than 2 hypertension medications.
- History of diabetes or fasting plasma glucose \>126 mg/dl or HbA1C\>=6.5% or prior treatment with antidiabetic medication.
- Have any past or present history of cardiovascular diseases (stroke, seizure, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
- Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence);
- Estimated GFR \< 60 ml/min/1.73 m2; albumin creatinine ratio ≥30 mg/g
- Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
- Anemia (men, Hct \< 38%; women, Hct \<36%)
- Inability to exercise on a treadmill
Where
- Birmingham, Alabama
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations