Empagliflozin Reversal of Arterial StiffnEss in Aging

NCT06506422 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2097602
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Empagliflozin

EXPERIMENTAL

10mg Empagliflozin daily for 12 weeks

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

10mg Placebo daily for 12 weeks

Drug: Placebo

Interventions

Placebo DRUG

10mg Placebo daily for 12 weeks

Also known as: Inactive

Placebo

Empagliflozin 10 MG DRUG

10mg Empagliflozin daily for 12 weeks

Also known as: Active

Empagliflozin

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Interventions

empagliflozin; Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Camila Manrique, MD

CONTACT

(573) 882-2554; manriquec@health.missouri.edu

Andrea Atkins, BSN

CONTACT

(573) 884-1222; wiesa@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: double-blinded randomized placebo control trial

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: August 18, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)