SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT04907214
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This project will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.

Key Dates

Start date
Jul 29, 2021
Status verified
Dec 2023
Primary completion
Dec 8, 2023
Completion
Dec 8, 2023

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin
    Individuals receive empagliflozin 25mg/day orally for 12 weeks

Primary Outcome Measure

Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months [ Time Frame: Baseline to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Nashville, TN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Vanderbilt University Medical Center· Nashville, TN

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