RECRUITING Not applicable ClinicalTrials.gov

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Sponsor: University of Alabama at Birmingham • ClinicalTrials.gov ID: NCT05216042

Registry updated: 2026-10-05

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Description

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.

Interventions

Study diet (Dietary supplement)
Participants will consume the study diet for 5 days provided by the clinical research unit's metabolic kitchen (at UAB)
Exercise capacity VO2 max determination (Other)
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.
Exercise Challenge (Other)
Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill and will also undergo a resting energy expenditure test.
Glucose Challenge (Other)
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.

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

Conditions

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

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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