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

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 15, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

May 31, 2027

Conditions
Diabetes MellitusCardiovascular DiseasesInsulin Sensitivity/ResistanceMetabolic DiseaseNatriuretic PeptidesMetabolismEnergy 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.

Trial Locations (1)

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Alabama at Birmingham

OTHER