RecruitingPhase 1 / Phase 2

The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether empagliflozin can lower swelling and irritation, called inflammation, in body fat. It also looks at how fat inflammation relates to blood vessel health and signs of heart disease risk. It is for adults with obesity and metabolic syndrome, a group of health problems that raise the risk of heart disease and diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, have a BMI of 35 or higher, and be able to give informed consent. BMI is a measure of weight compared with height.
  • Have metabolic syndrome: at least 3 of the following 5 signs.
  • Blood pressure of 130/85 or higher on either number, or take blood pressure medicine for at least 1 month.
  • Triglycerides, a type of blood fat, of 150 mg/dL or higher, or take medicine aimed at lowering them.
  • HDL, or “good” cholesterol, below 40 mg/dL for males or below 50 mg/dL for females.
  • Blood sugar after fasting of 100 mg/dL or higher, or take medicine to lower blood sugar.
  • Waist size of at least 102 cm for males or 88 cm for females.

Who can't join

  • Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c of 9% or higher, a measure of average blood sugar). Diabetes medicines in the past month other than a steady dose of metformin or a sulfonylurea. Any GLP-1 agonist or co-agonist, or SGLT2 inhibitor, in the past 3 months.
  • Pregnancy or breastfeeding. Anyone who could become pregnant must have had surgery to prevent pregnancy or use an IUD, hormonal birth control, or a barrier method.
  • A heart attack in the past 6 months; heart-related chest pain; serious heart rhythm problems; heart failure; certain heart valve or heart muscle problems; or certain blocks in the heart’s electrical signals. Also excluded: deep vein blood clots, blood clots in the lungs, a pacemaker or implanted defibrillator, or a history of serious brain or nerve disease, such as stroke or a mini-stroke.
  • Past pancreas inflammation or surgery; immune system or blood disorders; serious gut problems that affect medicine absorption; advanced liver disease with scarring; or kidney filtering level (eGFR) below 45. Other illnesses needing regular medicine may also exclude you if they could make the study unsafe or affect its results.
  • Steroid medicine that affects the whole body for more than 7 days in a row in a month; medicines to prevent blood clots; or certain water pills (furosemide, torsemide, bumetanide, or ethacrynic acid). Also excluded: an experimental drug in the past month, allergy to study medicines or their ingredients, or another reason the medicine’s label says you should not take it.
  • A history of alcohol abuse (more than 14 drinks per week for men or 7 for women) or illegal drug use. Previous assignment to a group in this trial, a mental condition that prevents understanding the study, or inability to follow study rules or return for visits.
  • Men who are not circumcised or have had inflammation of the penis head. Past urine leakage; more than 3 episodes of vaginal and vulva inflammation per year or severe symptoms; past severe infection around the genitals called Fournier’s gangrene; at least 3 urinary tract infections per year; or a past kidney infection.
  • Low blood pressure that causes symptoms, or conditions that make fluid loss more likely. Poor blood flow in the limbs, nerve damage, past foot sores, or past removal of part of a leg or foot.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

TN