Neurovascular Effects of Empagliflozin

NCT07799441 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 202603388
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does empagliflozin improve endothelial function?
2. 2.Does empagliflozin improve sympathetic nervous system function?

Conditions

Blood Pressure; Endothelial Dysfunction

Keywords

Sodium-glucose cotransporter 2 inhibition; Prehypertension; Vascular Function

Outcome Measures

Primary Outcomes (1)

• Macrovascular endothelial function as assessed by brachial artery flow-mediated dilation (FMD)

  The brachial artery will be imaged using high-resolution Doppler ultrasound at baseline and following a period of forearm blood-flow occlusion induced by an inflatable blood pressure cuff. FMD will be calculated as the percentage (%) increase in brachial artery diameter from baseline following cuff release, reflecting the ability of the brachial artery to dilate in response to increased blood flow and shear stress. Higher FMD values indicate greater endothelium-dependent vasodilatory function.

  At the end of each 2-week treatment period

Secondary Outcomes (1)

• Sympathetic nervous system function as assessed by muscle sympathetic nerve activity

  At the end of each 2-week treatment period

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Participants will receive Empagliflozin (25 mg once a day) for 2 weeks.

Drug: Empagliflozin (EMPA); Other: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive placebo pills identical in appearance and taste.

Drug: Empagliflozin (EMPA); Other: Placebo

Interventions

Empagliflozin (EMPA) DRUG

Oral ingestion for 2 weeks

Empagliflozin; Placebo

Placebo OTHER

Oral placebo for 2 weeks.

Empagliflozin; Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Kanokwan Bunsawat: lead

Study Sites (1)

Integrative Neurovascular Physiology Laboratory - University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Prehypertension

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kanokwan Bunsawat, PHD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kanokwan Bunsawat, PHD

CONTACT

319-335-1859; kanokwan-bunsawat@uiowa.edu

Nicholas Carlini, PHD

CONTACT

484-947-7574; nicholas-carlini@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind (1:1), randomized, placebo-controlled crossover study design. Participants with prehypertension will be randomized to receive either placebo or Empagliflozin for 2 weeks before crossing over to the opposite intervention arm after a 2-week washout period. The participants, research team members, principal investigator(s), and outcomes assessor will be blinded to all study conditions. Randomization and dispensing of the study drug and placebo will be performed by an outside, third party, organization not affiliated with the research team/project.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double-blind, placebo-controlled, crossover intervention.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

US (1)