Actively Recruiting
Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus
Led by Medanta, The Medicity, India · Updated on 2024-12-05
200
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the early postoperative period, hyperglycemia is frequently seen in renal transplant recipients primarily because of high doses of immunosuppressive therapy. Many of these patients have pre-existing type 2 diabetes (T2D). However, 10-20% of renal transplant recipients develop new onset persisting hyperglycemia following renal transplantation, known as posttransplant diabetes mellitus (PTDM). These patients need optimal glycemic control in order to prevent development of cardiovascular and de novo renal disease. Most of these patients receive insulin therapy following transplantation, as they receive steroid therapy and oral hypoglycemic agents are better avoided. However, as steroids are tapered and need for insulin diminishes, several anti-diabetic agents are initiated off-label, such as metformin, DDP-4 inhibitors and sulfonylureas. Sodium-glucose cotransporter-2 (SGLT2) inhibitors exhibit nephroprotective effects in individuals with native kidney disease, with or without type 2 diabetes. However, the data regarding the safety and glycemic efficacy of these glucose-lowering agents in the renal transplant setting are scarce. DPP-4 inhibitors are glucose-lowering agents used in patients with CKD. For instance, linagliptin is used in all eGFRs without dose modification. The data regarding the safety and efficacy of linagliptin are scarce in patients following renal transplantation. Since patients following renal transplantation receive immunosuppressants and steroids, which may affect their body composition. Effect of SGLT2 inhibitors or DPP-4 inhibitors on body composition in patients following renal transplantation is not well established. In this study, we aimed to examine the safety and effect of empagliflozin (an SGLT2 inhibitor) versus linagliptin (an DDP-4 inhibitor) on the glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus.
CONDITIONS
Official Title
Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 30 years or older with diabetes mellitus diagnosed before or after kidney transplant
- At least 3 months have passed since kidney transplantation
- Stable kidney function with less than 20% change in serum creatinine in the past month and eGFR over 30 ml/min/1.73 m2
- On stable immunosuppressive therapy for at least one month
- Medically stable based on medical history, physical exam, and lab tests
- Willing and able to follow study restrictions and provide informed consent
You will not qualify if you...
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplant, or diabetes caused by pancreatitis or pancreatectomy
- Unstable or highly variable blood sugar control making stable management unlikely
- Body mass index (BMI) of 18 kg/m2 or less
- Current eating disorder or significant weight change (5% gain or loss) within 12 weeks before screening
- Estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2
- Known allergies or contraindications to empagliflozin or linagliptin
- History of repeated urinary tract infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Division Of Endocrinology & Diabetes, Medanta The Medicity
Gurgaon, Haryana, India, 122001
Actively Recruiting
Research Team
M
Mr Surender, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here