Improved Insulin Sensitivity With Angiotensin Receptor Neprilysin Inhibition in Individuals With Obesity and Hypertension.
J Jordan, R Stinkens, T Jax...
https://pubmed.ncbi.nlm.nih.gov/27542885Actively Recruiting
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID04055428
The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)
Led by University of Alabama at Birmingham · Updated on 2025-07-03
200
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of natriuretic peptide (NP) augmentation on metabolic health in Black individuals, who have a higher risk of cardiometabolic diseases due to decreased insulin sensitivity. The study explores how low levels of NPs, hormones from the heart that regulate metabolism, may contribute to this increased risk. By increasing NP levels, the study aims to understand and potentially improve metabolic health and insulin sensitivity in this population. The trial compares two treatments over 12 weeks: sacubitril/valsartan, which increases NP levels by inhibiting the enzyme neprilysin, and valsartan alone, which does not affect NP levels. Participants will take their assigned medication twice daily. The study measures changes in insulin sensitivity using intravenous glucose tolerance tests (IVGTT) and assesses energy expenditure at rest and during exercise. It also examines post-meal GLP-1 hormone responses. Participants will undergo baseline and 12-week follow-up assessments including metabolic testing, treadmill exercise for oxygen consumption measurement, blood tests for NP and GLP-1 levels, and insulin sensitivity evaluation. Researchers will track changes in insulin sensitivity, energy use, and metabolic markers to evaluate treatment effects. The trial involves adult Black individuals and continues until May 2027, with all evaluations conducted under medical supervision.
CONDITIONS
Brief Title
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Self-identified race/ethnicity as African-American or Black
- Blood pressure between 120/80 mmHg and 160/100 mmHg
You will not qualify if you...
- Women who are pregnant, breastfeeding, or able to become pregnant without using birth control
- History of cardiovascular diseases such as stroke, heart attack, heart failure, or arrhythmia
- Blood pressure higher than 160/100 mmHg
- Body mass index over 45 kg/m²
- History of diabetes or fasting blood sugar ≥126 mg/dL or HbA1c ≥6.5%
- History of angioedema
- Current or past smoking within 12 months
- Reduced kidney function (eGFR <60 ml/min/1.73 m²) or high urine albumin
- Elevated liver enzymes above three times the normal limit
- Significant psychiatric illness or seizure disorder
- Consuming more than 2 alcoholic drinks daily
- Anemia based on specific blood count thresholds
- Inability to exercise on a treadmill
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take the assigned medication, either sacubitril/valsartan or valsartan, twice daily for 12 weeks. Insulin sensitivity and energy expenditure are assessed before and after the treatment period.
Baseline visit and end-of-treatment visit after 12 weeks
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
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Research Team
N
Nehal Vekariya, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Weight loss, saline loading, and the natriuretic peptide system.
Pankaj Arora, Jason Reingold, Aaron Baggish...
https://pubmed.ncbi.nlm.nih.gov/25595796Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial.
Jelena P Seferovic, Brian Claggett, Sara B Seidelmann...
https://pubmed.ncbi.nlm.nih.gov/28330649Racial differences in the association of NT-proBNP with risk of incident heart failure in REGARDS.
Nirav Patel, Mary Cushman, Orlando M Gutiérrez...
https://pubmed.ncbi.nlm.nih.gov/31162140