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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06095492
Other study ID # MMENDO01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date December 1, 2025

Study information

Verified date November 2023
Source Medanta, The Medicity, India
Contact Mr Surender, Phd
Phone 0124141414
Email yadavsurender89@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Empagliflozin 25 MG
Patient will get Empagliflozin 25
Linagliptin
linagliptin 5 mg once a day

Locations

Country Name City State
India Division Of Endocrinology & Diabetes, Medanta The Medicity Gurgaon Haryana

Sponsors (1)

Lead Sponsor Collaborator
Medanta, The Medicity, India

Country where clinical trial is conducted

India, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Estimated glomerular filtration rate (eGFR) Basline to 12 Months
Primary Spot urine albumin- creatinine ratio Basline to 12 Months
Primary Spot urine protein-creatinine ratio Basline to 12 Months
Secondary Changes in total fat content Measured by DEXA & BIA Basline to 12 Months
Secondary Changes in fat percentage Measured by DEXA & BIA Basline to 12 Months
Secondary Changes in lean mass Measured by DEXA & BIA Basline to 12 Months
Secondary Changes in bone mineral content Measured by DEXA & BIA Basline to 12 Months
Secondary Changes in fasting glucose Basline to 12 Months
Secondary Changes in HbA1c Basline to 12 Months
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