Status:
RECRUITING
Empagliflozin Reversal of Arterial StiffnEss in Aging
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Aging
Arterial Stiffness
Eligibility:
All Genders
60-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) re...
Detailed Description
The investigators will employ a double-blinded randomized placebo control trial to determine the effects of 12 weeks of sodium glucose co-transporter 2 (SGLT2) inhibition with empagliflozin (10 mg dai...
Eligibility Criteria
Inclusion
- Able to provide consent
- 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
- Diabetes
- 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
Key Trial Info
Start Date :
August 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06506422
Start Date
August 18 2024
End Date
February 28 2029
Last Update
January 8 2025
Active Locations (1)
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1
University of Missouri
Columbia, Missouri, United States, 65211