Health Trials

The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function

ConditionsObesityMetabolic Syndrome
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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 trial 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month

Triglycerides ≥ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)

High-density lipoprotein (HDL) < 40 mg/dL in males or < 50 mg/dL in females

Fasting blood glucose ≥ 100mg/dL or treatment with glucose-lowering medications

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 25 MG

    Drug

    Empagliflozin is an FDA-approved SGLT2 inhibitor used for the treatment of type 2 diabetes, with off-label use for diabetic kidney disease and for heart failure with reduced ejection fraction even in those without diabetes.

  • Placebo

    Drug

    Placebo consists of gelatin capsules.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Empagliflozin ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adipose tissue macrophages

Homeostatic adipose tissue macrophages are quantified

Time frame
12 weeks
2

Flow mediated dilation

Brachial artery diameter is measured under basal conditions and during reactive hyperemia

Time frame
12 weeks
3

Monocyte chemoattractant protein-1

Plasma monocyte chemoattractant protein-1 levels are quantified

Time frame
12 weeks

Secondary outcomes

1

Pro-inflammatory T cells

Pro-inflammatory T cells are quantified

Time frame
12 weeks
2

IL-6

Plasma IL-6 levels are quantified

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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