Treatment of Patients With Diabetic Kidney Disease

Assiut University

Status: Not yet enrolling

Conditions: Diabetic Kidney Disease

Treatments: Drug: lisinopril, enalapril; Drug: dapagliflozin, empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT06187493

diabetic kidney

Details and patient eligibility

About

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

Full 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)

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that suffer from Diabetic kidney disease (DKD)

Exclusion criteria

• Genital mycotic infections
• Urosepsis and Pyelonephritis
• Lower limb amputation
• diabetic Ketoacidosis
• Euglycemic DKA
• Acute Kidney Injury
• Hypoglycemia
• Fournier Gangrene
• Hypersensitivity Reactions
• Bone fracture
• Bladder cancer
• Hyperkalemia
• Dyslipidemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Efficacy of ACEi

Other group

Description:

Patients receive an ACEi medication, such as lisinopril, enalapril, or ramipril. These drugs work by blocking the production of angiotensin II, a hormone that can constrict blood vessels and raise blood pressure.

Treatment:

Drug: lisinopril, enalapril

Efficacy of SGLT2i

Other group

Description:

Patients receive an SGLT2i medication, such as dapagliflozin, empagliflozin, or canagliflozin. These drugs work by preventing the kidneys from reabsorbing glucose from the urine, leading to lower blood sugar levels and potentially reducing the risk of kidney damage.

Treatment:

Drug: dapagliflozin, empagliflozin