Empagliflozin Reversal of Arterial StiffnEss in Aging (ERASE-Aging)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Arterial Stiffness
• Intervention / Treatment: Drug: Empagliflozin 10 MG; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Camila Manrique, MD; Phone Number: (573) 882-2554; Email: manriquec@health.missouri.edu
• Study Contact Backup: Name: Andrea Atkins, BSN; Phone Number: (573) 884-1222; Email: wiesa@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri
      • Contact: Andrea Atkins, BSN; Phone Number: 573-884-1222; Email: wiesa@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empagliflozin; 10mg Empagliflozin daily for 12 weeks	Drug: Empagliflozin 10 MG; 10mg Empagliflozin daily for 12 weeks; Other Names: Active
Placebo Comparator: Placebo; 10mg Placebo daily for 12 weeks	Drug: Placebo; 10mg Placebo daily for 12 weeks; Other Names: Inactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Report	Baseline (day 0), Week 4, Week 8, Final (week 12)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; empagliflozin
• Other Study ID Numbers: 2097602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes