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NCT Number: NCT06745063

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Health

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, 65201-5275, United States

Location status: Recruiting

Location contact

Jaume Padilla Parellada, PhD

CONTACT

[email protected]

573-814-6552

Jaume Padilla Parellada, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Empagliflozin

Drug

12 week treatment with 10mg empagliflozin daily

Placebo

Drug

12 week treatment with 10mg placebo daily

Primary outcomes

  1. Carotid-femoral Pulse Wave Velocity (cfPWV)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaume Padilla Parellada, PhD

CONTACT

[email protected]

(573) 814-6552

Katherine M Burr

CONTACT

[email protected]

(573) 814-6550

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Missouri-Columbia

Registry information

Acronym: EMPA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 20, 2024
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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