No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for Black adults aged 18 and older to test if a medication can improve their metabolic health by boosting specific hormones. Participants will help understand the role these hormones play in diabetes risk.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years of age or older
I identify as African-American or Black
My blood pressure is between 120-160/80-100 mmHg
You may not be able to join if
I am pregnant, breastfeeding, or can become pregnant and not using birth control
I have had a heart attack or stroke
My blood pressure is above 160/100 mmHg
My BMI is over 45
I have a history of diabetes
I have had angioedema
I currently smoke or have smoked in the last year
I have significant psychiatric illness
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Eligibility 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 met…
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
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