SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot

NCT ID: NCT04907214

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2023-12-08

Brief 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.

Detailed Description

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

Conditions

Obesity; Pre-diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Empagliflozin

Individuals receive empagliflozin 25mg/day orally for 12 weeks

Group Type: EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type: DRUG

Oral empagliflozin daily

Interventions

Empagliflozin 25 MG

Oral empagliflozin daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mona Mashayekhi

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Mashayekhi, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

210907

Identifier Type: -

Identifier Source: org_study_id