NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals

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.

Conditions

• Diabetes Mellitus
• Cardiovascular Diseases
• Insulin Sensitivity/Resistance
• Metabolic Disease
• Natriuretic Peptides
• Metabolism
• Energy Expenditure

Interventions

DRUG

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.

DRUG

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.

OTHER

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.

DIETARY_SUPPLEMENT

Standardized Meals

Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.

OTHER

Exercise capacity VO2 maximum determination

Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-15

Primary Completion

2026-12-31

Completion

2027-05-31

FDA Drug

Yes

Countries

• United States

Study Locations