GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05216042
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Apr 1, 2022
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental: Low NP Genotype Group
    150 healthy adult participants with low NP genotype will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 5 days. On 5th day, the participants will come in for an exercise challenge test. On 6th day, participants will come in a fasting state and drink 75 gm of oral glucose, followed by blood collection every 8 hours.
  • Experimental: Active Comparator: High NP Genotype Group
    50 healthy adult participants with high NP genotype will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 5 days. On 5th day, the participants will come in for an exercise challenge test. On 6th day, participants will come in a fasting state and drink 75 gm of oral glucose, followed by blood collection every 8 hours.

Primary Outcome Measure

Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group. [ Time Frame: From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Nehal Vekariya, MS
[email protected]
205-934-7173
Pankaj Arora, MD (PRINCIPAL_INVESTIGATOR)

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University of Alabama at Birmingham· Birmingham, AL

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