RECRUITING

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Quick Facts

Study Start:2025-05-30
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06745063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) 30-45 kg/m2
  2. * 30-60 years of age at randomization
  3. * Evidence of arterial stiffening (defined as Carotid femoral PWV\>age-predicted) at screening visit (PMID: 20530030)
  1. * Unable to provide consent
  2. * Diabetes mellitus
  3. * Uncontrolled hypertension (\>180/90mmHg) or systolic \<100mmHg at screening visit
  4. * Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
  5. * Diagnosis of chronic kidney disease
  6. * Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
  7. * Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
  8. * Use of GLP-1 analogs or SGLT2 inhibitors
  9. * Use of hormone replacement therapy
  10. * Use of pharmacological therapy for weight loss
  11. * Body weight changes \>10% within the past 6 months
  12. * History of hypersensitivity to nitrates
  13. * History of ketoacidosis
  14. * History of recurrent UTIs or mycotic genital infections
  15. * Use of anticoagulants
  16. * Change in anti-hypertensive medication regimen (if in use) during the last 90 days
  17. * Pregnancy

Contacts and Locations

Study Contact

Jaume Padilla Parellada, PhD
CONTACT
(573) 814-6552
jaume.padillaparellada@va.gov
Katherine M Burr
CONTACT
(573) 814-6550
Katherine.Burr@va.gov

Principal Investigator

Jaume Padilla Parellada, PhD
PRINCIPAL_INVESTIGATOR
Harry S. Truman Memorial, Columbia, MO

Study Locations (Sites)

Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, 65201-5275
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jaume Padilla Parellada, PhD, PRINCIPAL_INVESTIGATOR, Harry S. Truman Memorial, Columbia, MO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Vascular Health