RecruitingPhase 2Phase 3NCT06506422

Empagliflozin Reversal of Arterial StiffnEss in Aging

SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging

Sponsor

University of Missouri-Columbia

Enrollment

80 participants

Start Date

Aug 18, 2024

Study Type

INTERVENTIONAL

Conditions

Arterial Stiffness Aging

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) reduces aging-related arterial stiffening.

Eligibility

Min Age: 60 YearsMax Age: 80 Years

Inclusion Criteria4

Able to provide consent
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 Criteria17

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

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Interventions

DRUGEmpagliflozin 10 MG

10mg Empagliflozin daily for 12 weeks

DRUGPlacebo

10mg Placebo daily for 12 weeks

Locations(1)

University of Missouri

Columbia, Missouri, United States

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NCT06506422

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