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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04055428
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sacubitril, Valsartan 97-103 mg Oral Tablet — DRUG
    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 — DRUG
    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 — OTHER
    An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.
  • Standardized Meals — DIETARY_SUPPLEMENT
    Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.
  • Exercise capacity VO2 maximum determination — OTHER
    Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.

Study Details

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.

Key Dates

Start date
Aug 15, 2020
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacubitril/Valsartan
    We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.
  • Active Comparator: Valsartan
    We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.

Primary Outcome Measure

Change in insulin sensitivity after natriuretic peptide augmentation [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Nehal Vekariya, MS
[email protected]
205-934-7173
Pankaj Arora, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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