[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05972564":3,"trial-entities:NCT05972564":95,"trial-summary:NCT05972564":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":54,"sex":61,"minimum_age":62,"maximum_age":16,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":86,"overall_officials":90,"references":93,"see_also_links":94},"NCT05972564","210907 (SADIE2)","The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function","RECRUITING","2026-12-30","2026-08","2026-08-05","2023-09-06","Vanderbilt University Medical Center","OTHER",true,"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.",null,[18,19],"Obesity","Metabolic Syndrome",[],"INTERVENTIONAL","BASIC_SCIENCE",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},74,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Empagliflozin 25 MG","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.",[35],"Empagliflozin Arm",[37],"Jardiance",{"type":31,"name":39,"description":40,"armGroupLabels":41},"Placebo","Placebo consists of gelatin capsules.",[42],"Placebo Arm",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Adipose tissue macrophages","Homeostatic adipose tissue macrophages are quantified","12 weeks",{"measure":49,"description":50,"timeFrame":47},"Flow mediated dilation","Brachial artery diameter is measured under basal conditions and during reactive hyperemia",{"measure":52,"description":53,"timeFrame":47},"Monocyte chemoattractant protein-1","Plasma monocyte chemoattractant protein-1 levels are quantified",[55,58],{"measure":56,"description":57,"timeFrame":47},"Pro-inflammatory T cells","Pro-inflammatory T cells are quantified",{"measure":59,"description":60,"timeFrame":47},"IL-6","Plasma IL-6 levels are quantified","ALL","18 Years",false,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Age 18+ years old\n2. Metabolic syndrome as defined by 3 or more of 5 criteria:\n\n   1. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month\n   2. Triglycerides ≥ 150 mg\u002FdL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)\n   3. High-density lipoprotein (HDL) \\\u003C 40 mg\u002FdL in males or \\\u003C 50 mg\u002FdL in females\n   4. Fasting blood glucose ≥ 100mg\u002FdL or treatment with glucose-lowering medications\n   5. Waist circumference ≥ 102 cm in males or ≥ 88cm in females\n3. BMI ≥ 35 kg\u002FM2\n4. Scheduled gastric bypass or gastric sleeve in approximately 90 days (range 90-270 days)\n5. The ability to provide informed consent\n\n   Exclusion Criteria:\n6. Type 1 diabetes.\n7. Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%.\n8. Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.\n9. Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.\n10. Treatment with an SGLT2 inhibitor in the last 3 months.\n11. 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.\n12. 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\n13. Presence of implanted cardiac defibrillator or pacemaker\n14. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack\n15. History of pancreatitis or pancreatic surgery\n16. History or presence of immunological or hematological disorders\n17. Clinically significant gastrointestinal impairment that could interfere with drug absorption\n18. History of advanced liver disease with cirrhosis\n19. Individuals with an eGFR\\\u003C45 mL\u002Fmin\u002F1.73 m2, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg\u002FdL and age in years: eGFR (mL\u002Fmin\u002F1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female)\n20. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)\n21. Treatment with anticoagulants\n22. 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\n23. History of alcohol abuse (\\>14 per week for men and \\>7 per week for women) or illicit drug use\n24. Treatment with any investigational drug in the one month preceding the study\n25. Previous randomization in this trial\n26. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study\n27. 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\n\n    Criteria Related to Known Adverse Effects of Drug:\n28. Uncircumcised men or men with history of balanitis\n29. History of urinary incontinence\n30. History of recurrent (\\>3) episodes of vulvovaginitis per year, or severe symptoms\n31. History of Fournier's gangrene\n32. History of recurrent (≥3) UTIs per year or pyelonephritis\n33. History of symptomatic hypotension or conditions predisposing to volume depletion\n34. Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations\n35. Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid\n36. Known or suspected allergy to trial medications, excipients, or related products\n37. Contraindications to study medications, worded specifically as stated in the product's prescribing information",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":12,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Nashville","Tennessee","37232","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Mona Mashayekhi, MD","CONTACT","615-875-6336","mona.mashayekhi@vumc.org",{"lat":84,"lon":85},36.16589,-86.78444,[87],{"name":88,"role":80,"phone":89,"email":82},"Mona Mashayekhi, MD, PhD","615-208-5037",[91],{"name":88,"affiliation":12,"role":92},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[19,18],[],{"nct_id":4,"found":14,"summary":99,"prompt_version":109},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study that will compare empagliflozin to a placebo (an inactive capsule). It plans to enroll 74 participants.","completed","Empagliflozin for Obesity and Metabolic Syndrome","This study is looking at how a medicine called empagliflozin might help people with obesity and metabolic syndrome. Empagliflozin is already approved for type 2 diabetes and heart failure. Researchers want to see if it can reduce inflammation (swelling) in fat tissue and improve how blood vessels work. You might be able to join if you are 18 or older and have metabolic syndrome, which means you meet at least three specific health criteria like high blood pressure or high triglycerides. The study will measure changes in fat tissue inflammation and blood vessel function after 12 weeks. The current status of this study is unclear, and it plans to enroll 74 participants.","The main measurements for this study are taken at 12 weeks.",112,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]