Recruiting
Phase 2
Phase 3

Empagliflozin

Sponsor:

University of Missouri-Columbia

Code:

NCT06506422

Conditions

Aging

Arterial Stiffness

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Empagliflozin 10 MG

Placebo

Study Details

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

Study ID

NCT06506422

Start date

Aug 18, 2024

Status verified date

Feb, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin

10mg Empagliflozin daily for 12 weeks

placebo comparator: Placebo

10mg Placebo daily for 12 weeks

Interventions

Empagliflozin 10 MG

10mg Empagliflozin daily for 12 weeks

Placebo

10mg Placebo daily for 12 weeks

Primary outcome measure

  • Carotid Femoral Pulse Wave Velocity (cfPWV) [ Time Frame: Baseline (day 0), Week 4, Week 8, Final (week 12) ]

Central Contacts and Locations

Central contacts

Camila Manrique, MD

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

Andrea Atkins, BSN

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

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Andrea Atkins, BSN

573-884-1222wiesa@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-02-06.