Recruiting
Phase 2

Sacubitril/Valsartan

Sponsor:

University of Alabama at Birmingham

Code:

NCT04055428

Conditions

Diabetes Mellitus

Cardiovascular Diseases

Insulin Sensitivity/Resistance

Metabolic Disease

Natriuretic Peptides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sacubitril, Valsartan 97-103 mg Oral Tablet

Valsartan 160 mg

Intravenous Glucose Tolerance Test

Standardized Meals

Exercise capacity VO2 maximum determination

Study Details

Brief 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

Study ID

NCT04055428

Start date

Aug 15, 2020

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults: Age more than or equal to 18 years of age
  • Self-identified race/ethnicity as African-American or Black
  • Blood pressure: 120-160/80-100 mmHg

Exclusion Criteria:

  • 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)
  • Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
  • BP more than 160/100 mmHg
  • BMI >45 kg/m2
  • History of diabetes or fasting plasma glucose >=126 mg/dL or HbA1C>=6.5%
  • History of angioedema
  • Current or past (<12 months) history of smoking
  • 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
  • Significant psychiatric illness or seizure disorder
  • More than 2 Alcoholic drinks daily
  • Anemia (men, Hct < 38%, Hb<13 g/dL; women, Hct <36%, Hb <12 g/dL)
  • Inability to exercise on a treadmill

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

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

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Natriuretic Peptides
  • Diabetes
  • Insulin Sensitivity
  • Energy Expenditure

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 2026-07-28.