NCT04907214

SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot

Completed Phase 1, PHASE2 Results posted Last updated 29 December 2023

What this trial tests

Phase 1, PHASE2 trial testing Empagliflozin 25 MG in Obesity in 29 participants. Completed in 8 December 2023.

Timeline

29 July 2021

Primary endpoint
8 December 2023

8 December 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	29
Start date	29 July 2021
Primary completion	8 December 2023
Estimated completion	8 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Empagliflozin 25 MG — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →
• Pre-diabetes — all drugs for Pre-diabetes →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 70, any sex, with Obesity or Pre-diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months Primary · Baseline to 12 weeks

Pro-inflammatory T helper type 1 cells are quantified using flow cytometry

Group	Value	95% CI
Empagliflozin	-1.6	± 1.8

Change in Flow-mediated Dilation After 3 Months Primary · Baseline to 12 weeks

Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia.

Group	Value	95% CI
Empagliflozin	-2.33	± 7.72

Change in Liver Steatosis at 3 Months Primary · Baseline to 12 weeks

Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP)

Group	Value	95% CI
Empagliflozin	0.17	± 28.12

Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks Secondary · Baseline to 2 weeks

Pro-inflammatory T cells are quantified using flow cytometry

Group	Value	95% CI
Empagliflozin	-0.5	± 5.0

Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months Secondary · Baseline to 12 weeks

IL-6 is quantified in plasma samples.

Group	Value	95% CI
Empagliflozin	0.078	± 0.717

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Empagliflozin

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (2 terms — click to expand)

Reaction	System	Empagliflozin
Skin infection	Skin and subcutaneous tissue disorders	—
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04907214 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.