RECRUITING

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-01
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05216042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults: Age more than or equal to 18; an equal number of Males and Females
  2. * Consent to the collection of genetic material
  3. * Willing to adhere to the study protocol
  1. * Age \<18, at screening.
  2. * BMI \>45 kg/m2.
  3. * Blood pressure more than 140/90 mmHg.
  4. * Participants who are taking more than 2 hypertension medications.
  5. * History of diabetes or fasting plasma glucose \>126 mg/dl or HbA1C\>=6.5% or prior treatment with antidiabetic medication.
  6. * Have any past or present history of cardiovascular diseases (stroke, seizure, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
  7. * 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);
  8. * Estimated GFR \< 60 ml/min/1.73 m2; albumin creatinine ratio ≥30 mg/g
  9. * Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
  10. * Anemia (men, Hct \< 38%; women, Hct \<36%)
  11. * Inability to exercise on a treadmill

Contacts and Locations

Study Contact

Nehal Vekariya, MS
CONTACT
205-934-7173
nvekariya@uabmc.edu

Principal Investigator

Pankaj Arora, MD, FAHA
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Pankaj Arora, MD, FAHA, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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