What this study is
The goal of this clinical trial is to examine whether empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, improves vascular and autonomic function in adults with prehypertension. The main questions this clinical trial aims to answer are:
1. Does empagliflozin improve endothelial function? 2. Does empagliflozin improve sympathetic nervous system function?
This clinical trial employs a double-blind, placebo-controlled crossover study lasting up to 6 weeks for participants with prehypertension and up to 2 weeks for normotensive participants. Participants with prehypertension will take empagliflozin or placebo for 2 weeks, separated by a 2-week washout. Normotensive participants will complete baseline, pre-treatment visits only and will serve as a control group.
What's being tested
- Empagliflozin (EMPA)
Intervention · DRUG
Oral ingestion for 2 weeks
- Placebo
Intervention · OTHER
Oral placebo for 2 weeks.
Study details
- Official title
- Neurovascular Effects of Empagliflozin in Mid-Life and Older Adults With Prehypertension
- Sponsor
- Kanokwan Bunsawat
- Conditions
- Blood Pressure · Endothelial Dysfunction
- Enrolling
- 100 people
- Starts
- 2026-09
- Est. completion
- 2029-01
- Design
- Triple-blind, randomized, crossover, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 75 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openIntegrative Neurovascular Physiology Laboratory - University of Iowa
Iowa City, Iowa, United States
- Kanokwan Bunsawat, PHD · Contact3193351859kanokwan-bunsawat@uiowa.edu
- Nicholas Carlini, PHD · Contact484-947-7574nicholas-carlini@uiowa.edu
Study team
Sponsor
Kanokwan Bunsawat
Study ID 202603388
Principal investigator
Kanokwan Bunsawat, PHD
University of Iowa
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.