Heart hormone boost may cut diabetes risk in black individuals — a trial puts it to the test
NCT ID NCT04055428
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
Black individuals often have lower levels of natriuretic peptides, heart hormones that help regulate metabolism. This trial tests whether raising those hormone levels with a drug called sacubitril/valsartan can improve insulin sensitivity and energy expenditure. About 200 Black adults with mildly elevated blood pressure but no heart disease will take either the study drug or a standard blood-pressure medication for 12 weeks. The goal is to see if boosting these hormones can lower the risk of diabetes in this population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination drug (sacubitril/valsartan) that boosts natriuretic peptide levels
- What this could lead to
- If it works, this could point toward a way to lower diabetes risk in Black individuals by targeting a hormone pathway that is often underactive in this population.
- What could go wrong
- This is a mid-stage trial with 200 participants, so results may not apply broadly. The drug also lowers blood pressure, which could complicate interpretation of metabolic effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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