RecruitingNot Applicable

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

United States200 participantsStarted 2022-04-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: About 3 hours on the exercise challenge visit day after consuming study meals for 4 days

Trial details

NCT IDNCT05216042

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Nehal Vekariya, MS

205-934-7173 nvekariya@uabmc.edu

View on ClinicalTrials.gov More Cardiovascular Diseases trials