NCT06731231

SGLT2i in Diabetic Patients with Renal Transplantation

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Post-transplant diabetes mellitus (PTDM), previously known as New Onset Diabetes After Transplantation defined as the diagnosis of diabetes mellitus (DM) in a previously non-diagnosed diabetic person after transplantation. PTDM is a common and serious post-transplant complication that threatens graft survival, increases incidence of infection and development of cardiovascular complications The primary objective of this study is to assess efficacy and safety of dapagliflozin in patients with post-transplantation diabetic patients

Detailed description

Post-transplant diabetes mellitus (PTDM), previously known as New Onset Diabetes After Transplantation defined as the diagnosis of diabetes mellitus (DM) in a previously non-diagnosed diabetic person after transplantation. PTDM is a common and serious post-transplant complication that threatens graft survival, increases incidence of infection and development of cardiovascular complications (Pham et al., 2020). The reported incidence of PTDM in kidney transplant recipients is 4% to 25% with 2- to 4-fold increased risk of cardiovascular and infectious complications as mentioned, which lowers patient survival. (Ying et al., 2020) Historically, PTDM has been variably defined as having random glucose level greater than 200 mg/dL, fasting glucose level greater than 140 mg/dL, or the need for insulin or oral hypoglycemic agents in the posttransplant period, although not widely used in clinical practice, oral glucose tolerance (OGTT) remains the gold standard for diagnosing PTDM. It should be noted that the algorithmic approach to the screening and diagnosis of PTDM is largely based on published kidney transplantation literature. However, it is speculated that the principles are relevant to all forms of solid organ transplantation (Sharif et al., 2000). Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are glucose lowering agents used in the treatment of type 2 DM by improving glycemic control, weight reduction, blood pressure control and albuminuria. the use of SGLT2i as a cardiorenal protective tool may be of particular value in renal transplant patients due to the risk of multiple comorbidities such as diabetes and hypertension. Recently, sodium-glucose transport protein 2 inhibitors (SGLT2i) emerged as a new class of therapeutics with beneficial effects on both cardiovascular (CV) and kidney outcomes in patients with diabetic kidney disease, nondiabetic proteinuric chronic kidney disease (CKD), and heart failure with and without diabetes in patients with native kidneys SGLT2i exert their protective effects through tubuloglomerular feedback and reduced intraglomerular pressure, glycosuria and altered metabolism, natriuresis and blood pressure control, and other additional diuretic and hematopoietic effects reduction which may provide unique benefits to improve cardiorenal outcomes in kidney transplant patients Evidence concerning the efficacy and safety of SGLT2i post renal transplantation is limited. Many of the mechanisms by which SGLT2i exert their benefit stand to prove equally as efficacious or more so among kidney transplant recipients as they have in patients with CKD. However, safety concerns have excluded transplant recipients from all large randomized control trials, and clinicians and patients alike are left to wonder if the benefits of these amazing drugs outweigh the risks.

Conditions

• Post-transplant Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SGLT2 inhibitor	Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are glucose lowering agents used in the treatment of type 2 DM by improving glycemic control, weight reduction, blood pressure control and albuminuria. the use of SGLT2i as a cardiorenal protective tool may be of particular value in renal transplant patients due to the risk of multiple comorbidities such as diabetes and hypertension. Recently, sodium-glucose transport protein 2 inhibitors (SGLT2i) emerged as a new class of therapeutics with beneficial effects on both cardiovascular (CV) and kidney outcomes in patients with diabetic kidney disease, nondiabetic proteinuric chronic kidney disease (CKD), and heart failure with and without diabetes in patients with native kidneys

Timeline

• Start date: 2024-03-15
• Primary completion: 2024-12-15
• Completion: 2025-01-01
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: Egypt