GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Age <18, at screening.

BMI >45 kg/m2.

Blood pressure more than 140/90 mmHg.

Participants who are taking more than 2 hypertension medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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 intervention

    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 intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental: Low NP Genotype GroupExperimental treatment 4 interventions
Group B: Active Comparator: High NP Genotype GroupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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
2

Change in Exercise Energy Expenditure between the high genotype and low genotype group.

Time frame
About 3 hours on the exercise challenge visit day after consuming study meals for 4 days
3

Change in miR-425 levels following a standardized oral glucose challenge in those with low ANP genotype.

Time frame
From 1st hour to 8th hour on the main study visit day after consuming study meals for 5 days
4

Change in miR-425 levels following a standardized exercise challenge in those with low ANP genotype.

Time frame
About 3 hours on the exercise challenge visit day after consuming study meals for 4 days

Secondary outcomes

1

Change in the NPs (ANP, BNP, NTproBNP) following the 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
2

Change in the serum glucose following the 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
3

Change in the serum insulin following the 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
4

Change in Resting Energy Expenditure (REE) between the two genotype groups.

Time frame
About 3 hours on the exercise challenge visit day after consuming study meals for 4 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator