Efficacy of ACEi Versus SGLT2i in the Treatment of Patients With Diabetic Kidney Disease : Head to Head RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- prevention of the development of DKD and alter its natural progression.
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that suffer from Diabetic kidney disease (DKD)
排除标准
- •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
研究组 & 干预措施
Efficacy of ACEi
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.
干预措施: lisinopril, enalapril (Drug)
Efficacy of SGLT2i
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.
干预措施: dapagliflozin, empagliflozin (Drug)
结局指标
主要结局
prevention of the development of DKD and alter its natural progression.
时间窗: baseline≥3 months-year
Primary Outcome: Time to development of DKD: Measured as the time from randomization to the first occurrence of any of the following events: Sustained (≥3 months) albumin-to-creatinine ratio (UACR) ≥300 mg/g End-stage kidney disease (ESKD) requiring dialysis or kidney transplantation Measurement Tools: UACR: Measured in urine samples using commercial laboratory assays. eGFR: Estimated using creatinine levels and demographic data through formulas like CKD-EPI. Cardiovascular events and mortality: Ascertained through medical records and national death registries. Unit of Measure: Time to DKD development: Years or months Change in UACR: mg/g eGFR decline: mL/min/1.73 m² per year Cardiovascular events and mortality: Incidence per 70patient-years
次要结局
未报告次要终点
研究者
Ismael ahmed amin mohammed alaraby
Director of the Health Affairs Directorate
Assiut University