Clinical trial NCT06187493: Treatment of Patients With Diabetic Kidney Disease
Official title: Efficacy of ACEi Versus SGLT2i in the Treatment of Patients With Diabetic Kidney Disease : Head to Head RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Kidney Disease
Keywords: Efficacy of ACEi versus SGLT2i
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: prevention of the development of DKD and alter its natural progression.
timeFrame: baseline≥3 months-year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohammed El-Tohamy, prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Walaa khalifa, prof
role: STUDY_DIRECTOR
References: