GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

This study, called GENESIS, is investigating how certain genetic differences affect heart hormones called Natriuretic Peptides (NPs) and their role in cardiometabolic health (conditions like heart disease and diabetes). Researchers want to understand if people with a specific genetic variation that leads to lower NP levels have different responses to diet and exercise. You might be able to join if you are an adult aged 18 or older, willing to provide genetic material, and can follow the study plan. The study will look for changes in NP levels and how your body uses energy after specific diet, exercise, and glucose challenges. The study aims to enroll 200 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 200 participants to compare how different genetic groups respond to diet and exercise challenges.
What's involved
You would consume a special diet for 5 days, have your exercise capacity measured, perform an exercise challenge, and undergo a glucose challenge with blood collections over 8 hours.
Compensation
Not stated in the trial record.
Follow-up
Your NP levels will be measured for 8 hours after a glucose challenge, and your energy expenditure will be measured for about 3 hours after an exercise challenge.

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NCT05216042

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Recruiting
NAAges 18+InterventionalBasic science
University of Alabama at Birmingham
~200 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Study dietExercise capacity VO2 max determinationExercise ChallengeGlucose Challenge

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group.
Measured over From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days
+3 more outcomes measured
Cardiovascular Diseases
Natriuretic Peptides
Cardiometabolic Diseases
Energy Expenditure
Glucose Metabolism
Exercise
Obesity
1 sites across 1 states
Alabama1
  • Pankaj Arora, MD, FAHA · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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

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
  • Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group.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.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.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.About 3 hours on the exercise challenge visit day after consuming study meals for 4 days