Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
NCT ID: NCT06745063
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-05-30
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Empagliflozin
12 week treatment with 10mg empagliflozin daily
Empagliflozin
12 week treatment with 10mg empagliflozin daily
Placebo
12 week treatment with 10mg placebo daily
Placebo
12 week treatment with 10mg placebo daily
Interventions
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Empagliflozin
12 week treatment with 10mg empagliflozin daily
Placebo
12 week treatment with 10mg placebo daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
60 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
University of Missouri-Columbia
OTHER
Responsible Party
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Principal Investigators
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Jaume Padilla Parellada, PhD
Role: PRINCIPAL_INVESTIGATOR
Harry S. Truman Memorial, Columbia, MO
Locations
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Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CARB-015-24S
Identifier Type: -
Identifier Source: org_study_id
2107866
Identifier Type: OTHER
Identifier Source: secondary_id
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