Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
30 – 60
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans with obesity to see how a medication called empagliflozin affects their arterial health. Participants will take either the medication or a placebo for 12 weeks.
Are You a Good Fit for This Trial?
Must not be takingGLP-1 analogsSGLT2 inhibitorsHormone replacement therapyWeight loss medicationsAnticoagulants
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Body mass index (BMI) 30-45 kilograms per square meter (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), or presence of Stage I hypertension or higher (PMID: 3035…
Inclusion Criteria:
* Body mass index (BMI) 30-45 kilograms per square meter (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), or presence of Stage I hypertension or higher (PMID: 30354655), or current use of antihypertensive agents
Exclusion Criteria:
* Unable to provide consent
* Diabetes mellitus
* Uncontrolled hypertension (\>180/90 millimeters of mercury) or systolic \<100 millimeters of mercury 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
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