The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)
University of Alabama at Birmingham
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.
Description
Black individuals are more likely to have a reduced insulin sensitivity which results in a greater risk for diabetes. However, the reasons for their decreased insulin sensitivity are not clearly understood. Natriuretic peptides (NPs) are hormones produced by the heart that is known to have a wide range of favorable metabolic effects. Studies indicate that lower NP levels are associated with a decreased insulin sensitivity and this may be causally related to the development of diabetes. Evidence suggests that Black individuals have low levels of NPs. Increased clearance of NPs by neprilysin, a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 fa…
Interventions
- DrugSacubitril, 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.
- DrugValsartan 160 mg
The subject will be randomized, in a double-blind manner to valsartan 160 mg twice daily for a period of 12 weeks.
- OtherIntravenous 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 SupplementStandardized Meals
Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.
- OtherExercise capacity VO2 maximum determination
Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.
Location
- University of Alabama at BirminghamBirmingham, Alabama