Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05972564
Other study ID # 210907 (SADIE2)
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 6, 2023
Est. completion date December 30, 2026

Study information

Verified date October 2023
Source Vanderbilt University Medical Center
Contact Mona Mashayekhi, MD
Phone 615-208-5037
Email mona.mashayekhi@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date December 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Age 18 to 70 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 6 months 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. Scheduled gastric bypass or gastric sleeve in approximately 90 days (range 90-150 days) 5. 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 Design


Related Conditions & MeSH terms


Intervention

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.
Placebo
Placebo consists of gelatin capsules.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adipose tissue macrophages Homeostatic adipose tissue macrophages are quantified 12 weeks
Primary Flow mediated dilation Brachial artery diameter is measured under basal conditions and during reactive hyperemia 12 weeks
Primary Monocyte chemoattractant protein-1 Plasma monocyte chemoattractant protein-1 levels are quantified 12 weeks
Secondary Pro-inflammatory T cells Pro-inflammatory T cells are quantified 12 weeks
Secondary IL-6 Plasma IL-6 levels are quantified 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2
Completed NCT05040971 - Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes Phase 3