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NOT YET RECRUITING

NCT07799441

PHASE4

Neurovascular Effects of Empagliflozin

Sponsor: Kanokwan Bunsawat

View on ClinicalTrials.gov

Summary

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.

Official title: Neurovascular Effects of Empagliflozin in Mid-Life and Older Adults With Prehypertension

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09

Completion Date

2029-01

Last Updated

2026-09-02

Healthy Volunteers

Yes

Conditions

Blood Pressure Endothelial Dysfunction

Interventions

DRUG

Empagliflozin (EMPA)

Oral ingestion for 2 weeks

OTHER

Placebo

Oral placebo for 2 weeks.

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

Locations (1)

Integrative Neurovascular Physiology Laboratory - University of Iowa

Iowa City, Iowa, United States