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Can a diabetes drug shield aging blood vessels?

NCT ID NCT07799441

Disease control Sponsor: Kanokwan Bunsawat Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether empagliflozin, a drug used for diabetes, improves blood vessel and nerve function in adults aged 45 to 75 with prehypertension. Participants take the drug or a placebo for two weeks, then switch, while a control group with normal blood pressure is observed. Researchers measure how well arteries widen and how active the sympathetic nervous system is. The goal is to see if this drug could help prevent high blood pressure and related damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empagliflozin, an SGLT2 inhibitor drug taken by mouth for 2 weeks
What this could lead to
If it works, empagliflozin could become a way to protect blood vessels and nerves in people with prehypertension, potentially delaying the need for blood pressure drugs.
What could go wrong
This is a small, short-term trial in 100 people, so the results may not apply broadly. The drug can cause side effects like dehydration or urinary infections, and it is not yet clear if it helps this population.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

45 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 * Midlife and older (\>/= 45-75 yrs) males and females * Body mass index 18-35 kg/m2 * Able to give informed consent Blood Pressure Status: Normotensive (control group) * Systolic (\<120 mmHg) and Diastolic (\<80 mmHg) Prehypertension (experimental group) * Systolic (120-129 mmHg) and Diastolic (\<80 mmHg) Exclusion Criteria * Age \<45 and/or \>75 yrs * BMI \>35 kg/m2 * Blood pressure: Systolic (\>130 mmHg) and Diastolic (\>80 mmHg) * Anti-hypertensive therapy * Type 2 diabetes (blood glucose \>126 mg/dL or HbA1c \>6.2%) * Currently prescribed SGLT2i medication * Currently prescribed GLP-1 medication * Currently prescribed Beta-Blocker medication * Known or recently (last 6 months) diagnosed renal, pulmonary, and/or neurological diseases/disorders (chronic kidney disease, acute kidney injury, kidney stones, urinary tract infection, glomerulonephritis, chronic obstructive pulmonary disease, asthma, pulmonary embolism, epilepsy, multiple sclerosis, Parkinson's, peripheral neuropathy) * Known or recently (last 6 months) diagnosed cardiovascular and cerebrovascular disorders (heart failure, coronary artery disease, stroke, transient ischemic attack, cerebral aneurysm, arteriovenous malformation, cerebral venous thrombosis, dementia, Alzheimer's, moyamoya disease) * Secondary or resistant hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg despite treatment with at least 3 different classes of antihypertensive medications * History of cancer * Smoking or tobacco/cannabis use (current use or quit within the last 6 months) * Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate birth control * Psychiatric or psychological disorders * Hormone-based therapy * History of myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate \< 60 ml/min/1.73m2) * History of lactic acidosis * History of alcohol abuse * Severe infection within the last 30 days * Immunosuppressive therapy within the past year * Life expectancy \< 1 year * Study compliance: Unwilling to fast overnight * Known allergy to Empagliflozin

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Conditions

The condition(s) this trial relates to.

hypertensive disorder Prehypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood pressure Endothelial dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Integrative Neurovascular Physiology Laboratory - University of Iowa

    Iowa City, Iowa, 52242, United States

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