Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

NCT ID: NCT06745063

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2029-12-31

Brief Summary

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The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.

Detailed Description

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The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.

Conditions

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Obesity Vascular Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
double-blinded

Study Groups

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Empagliflozin

12 week treatment with 10mg empagliflozin daily

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

12 week treatment with 10mg empagliflozin daily

Placebo

12 week treatment with 10mg placebo daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

12 week treatment with 10mg placebo daily

Interventions

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Empagliflozin

12 week treatment with 10mg empagliflozin daily

Intervention Type DRUG

Placebo

12 week treatment with 10mg placebo daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) 30-45 kg/m2
* 30-60 years of age at randomization
* Evidence of arterial stiffening (defined as Carotid femoral PWV\>age-predicted) at screening visit (PMID: 20530030)

Exclusion Criteria

* Unable to provide consent
* Diabetes mellitus
* Uncontrolled hypertension (\>180/90mmHg) or systolic \<100mmHg at screening visit
* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
* Diagnosis of chronic kidney disease
* 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 GLP-1 analogs or SGLT2 inhibitors
* Use of hormone replacement therapy
* Use of pharmacological therapy for weight loss
* Body weight changes \>10% within the past 6 months
* History of hypersensitivity to nitrates
* History of ketoacidosis
* History of recurrent UTIs or mycotic genital infections
* Use of anticoagulants
* Change in anti-hypertensive medication regimen (if in use) during the last 90 days
* Pregnancy
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

University of Missouri-Columbia

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaume Padilla Parellada, PhD

Role: PRINCIPAL_INVESTIGATOR

Harry S. Truman Memorial, Columbia, MO

Locations

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Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jaume Padilla Parellada, PhD

Role: CONTACT

(573) 814-6552

Katherine M Burr

Role: CONTACT

(573) 814-6550

Facility Contacts

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Jaume Padilla Parellada, PhD

Role: primary

573-814-6552

Other Identifiers

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CARB-015-24S

Identifier Type: -

Identifier Source: org_study_id

2107866

Identifier Type: OTHER

Identifier Source: secondary_id

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