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

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

Inclusion Criteria3

  • 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 Criteria11

  • 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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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.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT05216042


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