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New treatment option for Obesity
Official title The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
ClinicalTrials.gov ID: NCT05972564
What this study is testing
What is Empagliflozin 25 MG?
Empagliflozin 25 MG is an investigational medicine, being studied as a potential treatment for obesity.
Also referred to as Jardiance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18+ years old
- Metabolic syndrome as defined by 3 or more of 5 criteria:
- 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
You likely can't join if
- Type 1 diabetes.
- Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%.
- Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.
- Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.
- Treatment with an SGLT2 inhibitor in the last 3 months.
- Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone surgical sterilization or to be using an...
See the full eligibility criteria
- Age 18+ years old
- Metabolic syndrome as defined by 3 or more of 5 criteria:
- 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
- Waist circumference ≥ 102 cm in males or ≥ 88cm in females
- BMI ≥ 35 kg/M2
- Scheduled gastric bypass or gastric sleeve in approximately 90 days (range 90-270 days)
- The ability to provide informed consent
- Type 1 diabetes.
- Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%.
- Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.
- Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.
- Treatment with an SGLT2 inhibitor in the last 3 months.
- 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.
- 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...
- Presence of implanted cardiac defibrillator or pacemaker
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- History of pancreatitis or pancreatic surgery
- History or presence of immunological or hematological disorders
- Clinically significant gastrointestinal impairment that could interfere with drug absorption
- History of advanced liver disease with cirrhosis
- 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...
- Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
- Treatment with anticoagulants
- 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
- History of alcohol abuse (\>14 per week for men and \>7 per week for women) or illicit drug use
- Treatment with any investigational drug in the one month preceding the study
- Previous randomization in this trial
- Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
- 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...
- Uncircumcised men or men with history of balanitis
- History of urinary incontinence
- History of recurrent (\>3) episodes of vulvovaginitis per year, or severe symptoms
- History of Fournier's gangrene
- History of recurrent (≥3) UTIs per year or pyelonephritis
- History of symptomatic hypotension or conditions predisposing to volume depletion
- Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations
- Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid
- Known or suspected allergy to trial medications, excipients, or related products
- Contraindications to study medications, worded specifically as stated in the product's prescribing information
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.