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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04907214
Other study ID # 210907
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 29, 2021
Est. completion date December 8, 2023

Study information

Verified date December 2023
Source Vanderbilt University Medical Center
Contact n/a
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 project 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.


Description:

This study will be expanded to include another 10 participants. Enrollment will begin July 1, 2023.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date December 8, 2023
Est. primary completion date December 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion criteria: 1. Age 18 to 70 years old 2. Impaired glucose tolerance (two-hour plasma glucose 140-199 mg/dL) or impaired fasting glucose (100-125mg/dL) or HbA1c 5.7-6.4% 3. BMI = 30 kg/M2 4. The ability to provide informed consent Exclusion criteria: Criteria Related to Medical Diagnoses/Conditions/Treatments: 1. Diabetes type 1 or type 2, as defined by a fasting plasma glucose of 126 mg/dL or greater, a two-hour plasma glucose of 200 mg/dL or greater, HbA1c =6.5%, or the use of anti-diabetic medication 2. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control 3. 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 4. Presence of implanted cardiac defibrillator or pacemaker 5. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack 6. History of pancreatitis or pancreatic surgery 7. History or presence of immunological or hematological disorders 8. Clinically significant gastrointestinal impairment that could interfere with drug absorption 9. History of advanced liver disease with cirrhosis 10. 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) 11. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) 12. Treatment with anticoagulants 13. 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 14. History of alcohol abuse (>14 per week for men and >7 per week for women) or illicit drug use 15. Treatment with any investigational drug in the one month preceding the study 16. Previous randomization in this trial 17. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study 18. 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: 19. Uncircumcised men or men with history of balanitis 20. History of urinary incontinence 21. History of recurrent (>3) episodes of vulvovaginitis per year, or severe symptoms 22. History of Fournier's gangrene 23. History of recurrent (=3) UTIs per year or pyelonephritis 24. History of symptomatic hypotension or conditions predisposing to volume depletion 25. Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations 26. Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid 27. Known or suspected allergy to trial medications, excipients, or related products 28. 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
Oral empagliflozin daily

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 Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months Pro-inflammatory T helper type 1 cells are quantified using flow cytometry Baseline to 12 weeks
Primary Change in Flow-mediated Dilation After 3 Months Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia. Baseline to 12 weeks
Primary Change in Liver Steatosis at 3 Months Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP) Baseline to 12 weeks
Secondary Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks Pro-inflammatory T cells are quantified using flow cytometry Baseline to 2 weeks
Secondary Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months IL-6 is quantified in plasma samples. Baseline to 12 weeks
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