Improving metabolic health in Black individuals using natriuretic peptide augmentation
The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)
This study is testing if a medication can boost certain hormones to improve metabolic health in Black individuals at risk for diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04055428 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of natriuretic peptide augmentation on cardiometabolic health specifically in Black individuals, who are at a higher risk for diabetes due to lower levels of these hormones. The study will utilize sacubitril/valsartan, an FDA-approved medication that inhibits neprilysin, to increase natriuretic peptide levels and potentially improve insulin sensitivity and energy expenditure. Participants will undergo various assessments, including intravenous glucose tolerance tests and standardized meals, to evaluate the impact of the intervention on their metabolic health. The goal is to better understand the relationship between natriuretic peptides and the risk of cardiometabolic diseases in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are Black adults aged 18 and older with blood pressure between 120-160/80-100 mmHg.
Not a fit: Patients with a history of cardiovascular diseases, diabetes, or significant renal or hepatic issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved metabolic health and reduced diabetes risk among Black individuals.
How similar studies have performed: Previous studies have shown that natriuretic peptide augmentation can improve metabolic health in other populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Pankaj Arora, MD, FAHA — University of Alabama at Birmingham
- Study coordinator: Nehal Vekariya, MS
- Email: nvekariya@uabmc.edu
- Phone: 205-934-7173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.