Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients with pre-transplantation type 2 diabetes (T2D) and new-onset diabetes post liver transplantation (NODAT) are managed with multiple doses of subcutaneous insulin (MSI) following liver transplantation. As these patients receive oral glucocorticoids (mostly prednisolone) and immunosuppressants, which elevate blood glucose levels, multiple doses of insulin are usually required. After 2-3 months, when steroid doses are tapered and doses of immunosuppressants stabilize, insulin requirements subside and several oral hypoglycemic agents are initiated, such as metformin and sitagliptin. However, these agents are prescribed off-label as the data regarding the safety and efficacy of these agents in patients with liver transplantation are scarce. Furthermore, several patients with liver transplantation develop fatty liver (liver steatosis) several months after transplantation, which is a risk factor for liver dysfunction. SGLT-2 inhibitors are reported to have favorable effect on liver fat accumulation in patients with T2D. However, the effect of SGLT-2 inhibitor on liver fat accumulation after liver transplantation has not been evaluated. Chronic liver disease is associated with changes in body composition, especially increase in visceral fat and decrease in skeletal muscle mass. Data regarding the changes in body composition following liver transplantation are scarce. In this RCT, Investigators aim to evaluate the effect of dapagliflozin vs sitagliptin on liver fat accumulation; body composition variables; and safety and efficacy of these oral hypoglycemic agents in patients with diabetes and liver transplantation

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of diabetes (pre-transplantation type 2 diabetes or new onset diabetes after transplantation)

• Subjects taking insulin and/or metformin and/or sulfonylurea.

• Body mass index (BMI) \>=18.5 kg/m2

Locations
Other Locations
India
Division Of Endocrinology & Diabetes, Medanta The Medicity
RECRUITING
Gurgaon
Contact Information
Primary
Mr Surender, M.Sc
yadavsurender89@gmail.com
01244141414
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Dapa Group
Patients with diabetes mellitus will receive dapagliflozin 10 mg once daily. Glycemic equipoise will be maintained between the two groups by adjusting insulin doses and/or metformin and/or sulfonylurea; maintaining target fasting glucose, post-prandial glucose and glycated hemoglobin (HbA1c) in accordance with the ADA 2021
Active_comparator: Sita Group
Patients with diabetes mellitus will receive sitagliptin 100 mg once daily.Glycemic equipoise will be maintained between the two groups by adjusting insulin doses and/or metformin and/or sulfonylurea; maintaining target fasting glucose, post-prandial glucose and glycated hemoglobin (HbA1c) in accordance with the ADA 2021
Sponsors
Leads: Medanta, The Medicity, India

This content was sourced from clinicaltrials.gov