Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation

Launched by MEDANTA, THE MEDICITY, INDIA · Sep 6, 2021

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ClinConnect Summary

This clinical trial is studying how two medications, dapagliflozin and sitagliptin, affect liver fat and body composition in patients who have diabetes and have undergone a liver transplant. After a liver transplant, many patients experience changes in their blood sugar levels and can develop fatty liver, which can lead to further health complications. The researchers want to find out if dapagliflozin, a type of medication known as an SGLT-2 inhibitor, can help reduce liver fat and improve body composition compared to sitagliptin, which is commonly used to manage blood sugar levels.

To participate in the trial, individuals must have a diagnosis of diabetes (either type 2 diabetes before the transplant or new-onset diabetes afterward) and be taking certain diabetes medications. They should also have a body mass index (BMI) of 18.5 or higher. However, those with type 1 diabetes, severe kidney problems, or certain liver issues, among other exclusions, will not be eligible. Participants in the trial can expect to receive either dapagliflozin or sitagliptin and will be monitored for any effects on liver fat and body composition, helping to better understand how these medications work in liver transplant patients.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of diabetes (pre-transplantation type 2 diabetes or new onset diabetes after transplantation)
• • 2. Subjects taking insulin and/or metformin and/or sulfonylurea.
• • 3. Body mass index (BMI) \>=18.5 kg/m2
• Exclusion Criteria:
• • 1. Type 1 diabetes
• • 2. Estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2, calculated by the Chronic Kidney Disease - Epidemiology (CKD-EPI) equation
• • 3. Liver aminotransferases \>3 times the upper limit of the reference range (upper normal limit AST or ALT \>=40 units/L)
• • 4. History of recurrent urinary tract infection
• • 5. History or current acute or chronic pancreatitis
• • 6. Pregnancy
• • 7. Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).