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GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

RecruitingNAAges 18 Years - anyAllUniversity of Alabama at Birmingham
NCT05216042 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 cardi

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📋 Eligibility rules (as published)
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
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What it tests

  • Study diet
  • Exercise capacity VO2 max determination
  • Exercise Challenge
  • Glucose Challenge
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Where

1 site
University of Alabama at Birmingham
Birmingham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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