RecruitingNot ApplicableNCT05216042

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Atrial Natriuretic Peptide and Regulation of Cardiometabolic Health: A Genotype-Guided Human Physiological Study

Sponsor

University of Alabama at Birmingham

Enrollment

200 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Glucose metabolism Exercise Obesity Cardiovascular Diseases Cardiometabolic Diseases Natriuretic Peptides Energy Expenditure

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The GENESIS study is exploring how a person's genes affect certain heart-protective hormones called natriuretic peptides, and how this relates to heart and metabolic health. The goal is to better understand why some people are more protected against heart disease than others based on their genetics. You may be eligible if: - You are 18 years or older - You are willing to provide a genetic sample (e.g., blood or saliva) - You are willing to follow the study protocol, which includes exercise testing You may NOT be eligible if: - Your BMI is greater than 45 - Your blood pressure is above 140/90 mmHg - You are taking more than 2 blood pressure medications - You have diabetes, or your blood sugar levels are in the diabetic range - You have a history of cardiovascular disease (stroke, heart attack, heart failure, angina, etc.) - You are pregnant or breastfeeding, or could become pregnant and are not using contraception - You have reduced kidney function (eGFR below 60) or elevated urine protein - Your liver enzymes are significantly elevated - You have anemia - You are unable to exercise on a treadmill Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTStudy diet

Participants will consume the study diet for 5 days provided by the clinical research unit's metabolic kitchen (at UAB)

OTHERExercise 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.

OTHERExercise 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.

OTHERGlucose 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.