Empagliflozin Reversal of Arterial StiffnEss in Aging | NCT06506422

Studies
Empagliflozin Reversal of Arterial StiffnEss in Aging

NCT06506422

Sponsor

University of Missouri-Columbia

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

80Estimated

Phase

Phase 2Phase 3

Conditions

Aging
Arterial Stiffness

Interventions

Empagliflozin 10 MG
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2024Actual

Primary Completion Date

Oct 31, 2028Estimated

Completion Date

Feb 28, 2029Estimated

First Submitted Date

Jul 11, 2024

First Submission Date that Met QC Criteria

Jul 11, 2024

First Posted Date

Jul 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Empagliflozin	Experimental	10mg Empagliflozin daily for 12 weeks	Drug: Empagliflozin 10 MG
Placebo	Placebo Comparator	10mg Placebo daily for 12 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin 10 MG	Drug	10mg Empagliflozin daily for 12 weeks	Empagliflozin

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Camila Manrique, MD	Contact	(573) 882-2554		manriquec@health.missouri.edu
Andrea Atkins, BSN	Contact	(573) 884-1222		wiesa@health.missouri.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri	Recruiting	Columbia	Missouri	65211	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570240	empagliflozin
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

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