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NCT07799441
Neurovascular Effects of Empagliflozin
Conditions: Blood Pressure, Endothelial Dysfunction
Sex: All
Ages: 45 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 100
Sponsor: Kanokwan Bunsawat
Location: Integrative Neurovascular Physiology Laboratory - University of Iowa Iowa City Iowa
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.
Eligibility Criteria
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 (\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
Source: ClinicalTrials.gov (NCT07799441). StuddyBuddy aggregates publicly available trial information.