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/PHASE3
80 participants
INTERVENTIONAL
2024-08-18
2029-02-28
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
10mg Empagliflozin daily for 12 weeks
Empagliflozin 10 MG
10mg Empagliflozin daily for 12 weeks
Placebo
10mg Placebo daily for 12 weeks
Placebo
10mg Placebo daily for 12 weeks
Interventions
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Empagliflozin 10 MG
10mg Empagliflozin daily for 12 weeks
Placebo
10mg Placebo daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses)
* Stable anti-hypertensive medication regimen (if in use) for at least 90 days
* Evidence of arterial stiffening (defined as carotid-femoral PWV \>/= 8 m/s) at the time of screening visit.
Exclusion Criteria
* BMI\>/= 45kg/m2
* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
* Estimated glomerular filtration rate GFR \< 29 mL/min
* 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 hormone replacement therapy
* Body weight change ≥10% within the last 6 months
* Uncontrolled hypertension during screening visit (\>180/110 mmHg)
* Symptomatic hypotension and/or a SBP \<100 mmHg
* History of ketoacidosis
* High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments and orthostatic blood pressure measurements)
* Anticipated need of prolonged fasting
* History of recurrent UTIs or mycotic genital infections
* Following a low-carbohydrate diet (\<20 grams/day)
* Participation in regular exercise \> 3 days/week per week at a moderate or vigorous intensity
* Known sensitivity to nitrate medications
60 Years
80 Years
ALL
Yes
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Camila Manrique, MD
Professor of Medicine
Locations
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University of Missouri
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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2097602
Identifier Type: -
Identifier Source: org_study_id
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