Neurovascular Effects of Empagliflozin

ConditionsBlood Pressure Endothelial Dysfunction

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age45-75

SponsorKanokwan Bunsawat

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Midlife and older (>/= 45-75 yrs) males and females

Body mass index 18-35 kg/m2

Able to give informed consent

Systolic (<120 mmHg) and Diastolic (<80 mmHg) Prehypertension (experimental group)

Disqualifiers

Age <45 and/or >75 yrs

BMI >35 kg/m2

Blood pressure: Systolic (>130 mmHg) and Diastolic (>80 mmHg)

Anti-hypertensive therapy

Trial design

Design model

Crossover

Treatments tested in this trial

Empagliflozin (EMPA)
Drug
Oral ingestion for 2 weeks
Placebo
Other intervention
Oral placebo for 2 weeks.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: EmpagliflozinExperimental treatment 2 interventions

Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

At the end of each 2-week treatment period

Secondary outcomes

Sympathetic nervous system function as assessed by muscle sympathetic nerve activity

Muscle sympathetic nerve activity (MSNA) will be measured using microneurography, in which a recording electrode will be inserted into a nerve of the lower leg to directly record sympathetic nerve activity. Sympathetic bursts will quantified as burst frequency (bursts/min) and burst incidence (bursts/100 heartbeats). Higher values indicate greater MSNA sympathetic nerve activity.

Time frame

At the end of each 2-week treatment period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kanokwan Bunsawat

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: