Comparing Dapagliflozin and Sitagliptin for Liver Fat in Diabetic Liver Transplant Patients
Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial
NA · Medanta, The Medicity, India · NCT05042505
This study is testing whether the medications dapagliflozin or sitagliptin can help reduce liver fat in people with diabetes who have had a liver transplant.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Medanta, The Medicity, India (other) |
| Locations | 1 site (Gurgaon, Haryana) |
| Trial ID | NCT05042505 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dapagliflozin versus sitagliptin on liver fat accumulation and body composition in patients with diabetes mellitus who have undergone liver transplantation. The study aims to enroll 100 patients, including those with pre-transplant type 2 diabetes and new-onset diabetes after transplantation. Participants will receive either dapagliflozin or sitagliptin, and their outcomes will be assessed through various demographic, clinical, and laboratory parameters. The trial is conducted following ethical guidelines and requires informed consent from all participants.
Who should consider this trial
Good fit: Ideal candidates include patients with type 2 diabetes who are undergoing or have undergone liver transplantation.
Not a fit: Patients with type 1 diabetes or significant kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective management strategies for diabetes in liver transplant patients, potentially reducing liver fat accumulation.
How similar studies have performed: While there is limited data on the specific use of dapagliflozin and sitagliptin in this population, SGLT-2 inhibitors have shown promise in managing liver fat in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Gurgaon, Haryana
- Division Of Endocrinology & Diabetes, Medanta The Medicity — Gurgaon, Haryana, India (RECRUITING)
Study contacts
- Study coordinator: Mr Surender, M.Sc
- Email: yadavsurender89@gmail.com
- Phone: 01244141414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Liver Transplant, Complications