What this study is
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.
What's being tested
- Sacubitril, Valsartan 97-103 mg Oral Tablet
Intervention · 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
Intervention · 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
Intervention · OTHER
An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.
- Standardized Meals
Intervention · 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
Intervention · OTHER
Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.
Study details
- Official title
- The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Diabetes Mellitus · Cardiovascular Diseases · Insulin Sensitivity/Resistance · Metabolic Disease · Natriuretic Peptides · Metabolism · Energy Expenditure
- Enrolling
- 200 people
- Starts
- 2020-08-15
- Est. completion
- 2027-05-31
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Nehal Vekariya, MS · Contact205-934-7173nvekariya@uabmc.edu
- Pankaj Arora, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID 300003702
Principal investigator
Pankaj Arora, MD, FAHA
University of Alabama at Birmingham
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.