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RecruitingNCT06745063EMPAUpdated Nov 14, 2025

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

A Phase 2 interventional study of Empagliflozin and Placebo in Obesity and Vascular Health, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.

Read the detailed description

The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.

02

Conditions studied

  • Obesity
  • Vascular Health

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body mass index (BMI) 30-45 kg/m2
  • 30-60 years of age at randomization
  • Evidence of arterial stiffening (defined as Carotid femoral PWV>age-predicted) at screening visit (PMID: 20530030)

Exclusion criteria

Exclusion Criteria:

  • Unable to provide consent
  • Diabetes mellitus
  • Uncontrolled hypertension (>180/90mmHg) or systolic \<100mmHg at screening visit
  • Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
  • Diagnosis of chronic kidney disease
  • Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
  • Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
  • Use of GLP-1 analogs or SGLT2 inhibitors
  • Use of hormone replacement therapy
  • Use of pharmacological therapy for weight loss
  • Body weight changes >10% within the past 6 months
  • History of hypersensitivity to nitrates
  • History of ketoacidosis
  • History of recurrent UTIs or mycotic genital infections
  • Use of anticoagulants
  • Change in anti-hypertensive medication regimen (if in use) during the last 90 days
  • Pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Empagliflozin

    12 week treatment with 10mg empagliflozin daily

    Drug: Empagliflozin

  • Placebo comparator
    Placebo

    12 week treatment with 10mg placebo daily

    Drug: Placebo

Interventions

  • DrugEmpagliflozin

    12 week treatment with 10mg empagliflozin daily

  • DrugPlacebo

    12 week treatment with 10mg placebo daily

06

What researchers measure

Primary outcomes

  1. Carotid-femoral Pulse Wave Velocity (cfPWV)

    cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points.

    Time frame: baseline (t0), week 4, week 8, week 12

07

Study locations

1 of 1 sites recruiting
  • Harry S. Truman Memorial, Columbia, MO
    Columbia, Missouri 65201-5275, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06745063
Lead sponsor
VA Office of Research and Development
Collaborators
University of Missouri-Columbia
Responsible party
Sponsor
First posted
Dec 20, 2024
Start date
May 30, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Nov 14, 2025

Study contacts

Jaume Padilla Parellada, PhD
Contact
jaume.padillaparellada@va.gov
(573) 814-6552
Katherine M Burr
Contact
Katherine.Burr@va.gov
(573) 814-6550
Jaume Padilla Parellada, PhD
principal investigator · Harry S. Truman Memorial, Columbia, MO

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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