Recruiting

Natriuretic Peptides

Sponsor:

University of Alabama at Birmingham

Code:

NCT05216042

Conditions

Cardiovascular Diseases

Natriuretic Peptides

Cardiometabolic Diseases

Energy Expenditure

Glucose Metabolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Study diet

Exercise capacity VO2 max determination

Exercise Challenge

Glucose Challenge

Study Details

Brief 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.

Conditions

Cardiovascular Diseases

Natriuretic Peptides

Cardiometabolic Diseases

Energy Expenditure

Glucose Metabolism

Study ID

NCT05216042

Start date

Apr 1, 2022

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Study diet

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

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

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

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 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Nehal Vekariya, MS

205-934-7173nvekariya@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Nehal Vekariya, MS

205-934-7173nvekariya@uabmc.edu

Principal Investigator:

Pankaj Arora, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-04-09.