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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07799441). StuddyBuddy aggregates publicly available trial information.