Empagliflozin Reversal of Arterial StiffnEss in Aging

Phase 2

Recruiting

• Conditions: Aging; Arterial Stiffness
• Interventions: Drug: Placebo; Drug: Empagliflozin 10 MG

• Registration Number: NCT06506422
• Lead Sponsor: University of Missouri-Columbia

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) reduces aging-related arterial stiffening.

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 daily), or matching placebo. Empagliflozin has been shown to decrease cardiovascular events and arterial stiffness in different populations. Placebo will be included for comparison purposes as empagliflozin is not a standard therapy for aging-associated arterial stiffness.

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Study Start: 2024-08-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2028-10-31
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	10mg Placebo daily for 12 weeks
Empagliflozin	Empagliflozin 10 MG	10mg Empagliflozin daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Carotid Femoral Pulse Wave Velocity (cfPWV)	Baseline (day 0), Week 4, Week 8, Final (week 12)	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.; Report

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States