NCT06187493

Treatment of Patients With Diabetic Kidney Disease

Efficacy of ACEi Versus SGLT2i in the Treatment of Patients With Diabetic Kidney Disease : Head to Head RCT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Due to irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns. So, this study aimed to compare the effectiveness of SGlT2i versus ACEi in the progression of diabetic kidney disease including progression of albuminuria. Doubling of serum creatinine and need for renal replacement therapy

Detailed description

Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT). Despite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (CKD) patients due to DKD that requires KRT. Hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. Irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns. ACE inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type I and type II. SGLT2i have become the new standard of care for slowing CKD progression in patients with type 2 diabetes mellitus (T2DM, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects. Research questions: Q1. Is there a significant effect of ACEi in treatment of patients with diabetic kidney disease. Q2: Is there is a significant effect of SGLT2i in treatment of patients with diabetic kidney disease. Q3: Which is more significantly efficient in treatment of patients with diabetic kidney disease (ACEi versus SGLT2i)

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	lisinopril, enalapril	1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both. 2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications. 3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.
DRUG	dapagliflozin, empagliflozin	1. Both arms should aim to achieve optimal blood pressure control, typically defined as a systolic blood pressure below 130 mmHg and a diastolic blood pressure below 80 mmHg. This can be achieved through lifestyle modifications, additional medications, or a combination of both. 2. Maintaining good glycemic control is also important for both arms. This can be achieved through diet, exercise, and diabetes medications. 3. Both arms may also receive other supportive care measures for DKD, such as protein restriction, dietary counseling, and management of other co-morbidities like anemia and hyperlipidemia.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-31
• Completion: 2025-12-31
• First posted: 2024-01-02
• Last updated: 2024-01-02