Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-60
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Empagliflozin
Drug12 week treatment with 10mg empagliflozin daily
Placebo
Drug12 week treatment with 10mg placebo daily
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: EmpagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
University of Missouri-Columbia
Collaborator
Source ClinicalTrials.gov