Effects of a diabetes medication on inflammation and heart health in obese patients
Official title: The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Run by Vanderbilt University Medical Center · NCT05972564 · Data updated 2026-11-12
This study tests if a diabetes medication called empagliflozin can help reduce inflammation and improve heart health in obese patients with metabolic syndrome.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 74 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | September 6, 2023 |
| Main results expected | June 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT05972564 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 with metabolic syndrome and a BMI of 35 kg/m² or higher, who are scheduled for gastric bypass or sleeve surgery.
✕Probably not a fit
Patients with type 1 diabetes or poorly controlled type 2 diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of the SGLT2 inhibitor empagliflozin on reducing inflammation in adipose tissue and improving endothelial function in obese patients with metabolic syndrome. The study aims to understand how this medication can potentially mitigate the chronic inflammation associated with obesity, which is linked to increased cardiovascular disease risk. Participants will be randomly assigned to receive either empagliflozin or a placebo, and various health metrics will be monitored throughout the trial.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic options for managing obesity-related inflammation and improving cardiovascular health.
How similar studies have gone: Other studies have shown promising results with SGLT2 inhibitors in managing metabolic conditions, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Age 18+ years old 2. Metabolic syndrome as defined by 3 or more of 5 criteria: 1. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month 2. Triglycerides ≥ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids) 3. High-density lipoprotein (HDL) \< 40 mg/dL in males or \< 50 mg/dL in females 4. Fasting blood glucose ≥ 100mg/dL or treatment with glucose-lowering medications 5. Waist circumference ≥ 102 cm in males or ≥ 88cm in females 3. BMI ≥ 35 kg/M2 4. The ability to provide informed consent Exclusion Criteria: 6\. Type 1 diabetes. 7. Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%. 8. Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month. 9\. Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months. 10\. Treatment with an SGLT2 inhibitor in the last 3 months. 11. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone surgical sterilization or to be using an intra-uterine device, hormonal contraceptive, or barrier methods of birth control. 12\. Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, -second- or third-degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy 13. Presence of implanted cardiac defibrillator or pacemaker 14. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack 15. History of pancreatitis or pancreatic surgery 16. History or presence of immunological or hematological disorders 17. Clinically significant gastrointestinal impairment that could interfere with drug absorption 18. History of advanced liver disease with cirrhosis 19. Individuals with an eGFR\<45 mL/min/1.73 m2, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg/dL and age in years: eGFR (mL/min/1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female) 20. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) 21. Treatment with anticoagulants 22. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult 23. History of alcohol abuse (\>14 per week for men and \>7 per week for women) or illicit drug use 24. Treatment with any investigational drug in the one month preceding the study 25. Previous randomization in this trial 26. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study 27. Inability to comply with the protocol in the opinion of the principal investigator, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study Criteria Related to Known Adverse Effects of Drug: 28\. Uncircumcised men or men with history of balanitis 29. History of urinary incontinence 30. History of recurrent (\>3) episodes of vulvovaginitis per year, or severe symptoms 31. History of Fournier's gangrene 32. History of recurrent (≥3) UTIs per year or pyelonephritis 33. History of symptomatic hypotension or conditions predisposing to volume depletion 34. Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations 35. Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid 36. Known or suspected allergy to trial medications, excipients, or related products 37. Contraindications to study medications, worded specifically as stated in the product's prescribing information
Where it's running
-
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Mona Mashayekhi, MD, PhD — Vanderbilt University Medical Center
- Study coordinator: Mona Mashayekhi, MD, PhD
- Email: mona.mashayekhi@vumc.org
- Phone: 615-208-5037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.