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NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
Sponsor: University of Alabama at Birmingham
Summary
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity \& energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population.
Official title: The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2020-08-15
Completion Date
2027-05-31
Last Updated
2025-07-03
Healthy Volunteers
Yes
Conditions
Interventions
Sacubitril, Valsartan 97-103 mg Oral Tablet
The subject will be randomized, in a double-blind manner to sacubitril/valsartan 97/103 mg twice daily for a period of 12 weeks.
Valsartan 160 mg
The subject will be randomized, in a double-blind manner to valsartan 160 mg twice daily for a period of 12 weeks.
Intravenous Glucose Tolerance Test
An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.
Standardized Meals
Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.
Exercise capacity VO2 maximum determination
Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.
Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States