The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Recruiting
Phase 1Phase 2Interventional Study
ObesityMetabolic Syndrome
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Basic Science
Participants needed
74 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for obese adults with metabolic syndrome. Participants will take the medication empagliflozin to see its effects on inflammation and heart health.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPoorly controlled Type 2 diabetesPregnancySerious neurologic diseaseAdvanced liver diseaseAlcohol abuse
You may be able to join if
I am 18 years or older.
I have metabolic syndrome.
I have a BMI of 35 or higher.
I can give my consent to participate.
You may not be able to join if
I have Type 1 diabetes.
I have poorly controlled Type 2 diabetes.
I am pregnant or breastfeeding.
I have had a heart attack in the past 6 months.
I have a history of serious neurologic diseases.
I have advanced liver disease.
I have a history of alcohol abuse.
I cannot comply with the study requirements.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-infla…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.