Clinical trial

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT05216042

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionCardiovascular Diseases, Natriuretic Peptides, Cardiometabolic Diseases, Energy Expenditure, Glucose Metabolism, Exercise, Obesity

Full registry 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

Treatments and study arms

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.

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States
Nehal Vekariya, MSContact
Pankaj Arora, MDPrincipal Investigator