Is NCT05972564 recruiting in Nashville, TN?

Yes, NCT05972564 is currently recruiting participants at its Nashville, TN location. This obesity clinical trial is actively enrolling qualified participants.

How do I join the obesity clinical trial in Nashville?

To join this clinical trial in Nashville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Nashville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Obesity Clinical Trial in Nashville, TN

About This Obesity Study in Nashville

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.

Sponsor: Vanderbilt University Medical Center

Who Can Participate

Inclusion 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

Exclusion Criteria

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 vein thrombosis, pulmonary embolism, -second- or third-degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy

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 (mL/min/1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female)

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 Known Adverse Effects of Drug:

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT05972564) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obesity Treatment Options in Nashville, TN

If you're searching for obesity treatment options in Nashville, TN, this clinical trial (NCT05972564) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obesity specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obesity clinical trials near you to find additional studies recruiting in your area.

Obesity Clinical Trial in Nashville, TN

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