RightFit
RecruitingNot applicable

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how heart hormones respond to exercise and a glucose (sugar) challenge in people with gene changes linked to lower levels of these hormones. It aims to better understand heart and metabolic health, including how the body handles sugar. The study is for adults age 18 or older.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older. The study plans to include equal numbers of males and females.
  • Agree to give a sample of genetic material.
  • Be willing to follow the study rules.

Who can't join

  • Body mass index (BMI), a measure of weight compared with height, above 45.
  • Blood pressure above 140/90, or taking more than 2 blood pressure medicines.
  • Past diabetes or treatment with diabetes medicine; fasting blood sugar above 126 mg/dL; or A1C, a measure of average blood sugar, of 6.5% or higher.
  • Past or current stroke, seizure, heart attack, heart failure, mini-stroke, heart-related chest pain, or abnormal heartbeat.
  • Pregnant, breastfeeding, or able to become pregnant but not using accepted birth control during the study. Not having sex is an accepted method.
  • Kidney filtering test (eGFR) below 60 mL/min/1.73 m², or urine albumin-to-creatinine ratio, a measure of protein in urine, of 30 mg/g or higher.
  • Liver blood tests (AST or ALT) above 3 times the upper normal limit; or anemia (low red blood cells), with hematocrit below 38% in men or 36% in women.
  • Unable to exercise on a treadmill.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

AL