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.
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
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
Parallel
Sacubitril, Valsartan 97-103 mg Oral Tablet
DrugThe 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
DrugThe 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 interventionAn assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.
Standardized Meals
Dietary supplementParticipants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.
Exercise capacity VO2 maximum determination
Other interventionEach participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.
Change in insulin sensitivity after natriuretic peptide augmentation
An assessment of the insulin sensitivity will be done at baseline and after 12 weeks of pharmacological intervention.
Change in energy expenditure after natriuretic peptide augmentation
An assessment of the resting energy expenditure will be done at baseline and after 12 weeks of pharmacological intervention.
Change in exercise energy expenditure after 12 weeks of pharmacological intervention.
During standardized protocol after 12 weeks of intervention, the energy expenditure will be calculated using metabolic cart.
Change in post-meal increase in GLP-1 levels
Change in GLP-1 levels after a standardized meal after 12 weeks of pharmacological intervention
Change in peak oxygen consumption after 12 weeks of pharmacological intervention.
Change in the peak oxygen consumption (VO2 max) after 12 weeks of intervention.
Change in fasting GLP-1 levels
Change in fasting GLP-1 levels after 12 weeks of pharmacological intervention
Change in Metabolomic Profile
The change in the metabolomic profile examined using standardized platforms after 12 weeks of intervention.
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University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
