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临床试验/NCT07757269
NCT07757269已完成不适用

ABO/Rh Blood Group Phenotypes as Independent Predictor of Treatment Outcomes in Diabetic Kidney Disease: A 1-Year Prospective Cohort Study

Cairo University1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
1
主要终点
the progression or therapeutic response of diabetic kidney disease

研究概览

简要总结

Background and aim: ABO blood groups are biologically plausible modulators of endothelial function, coagulation, and inflammation - pathways central to diabetic kidney disease (DKD). This study evaluates whether ABO/Rh phenotypes associate with differential treatment outcomes in DKD.

Methods: This 1-year prospective cohort study enrolled 161 adults with type 2 diabetes and established DKD (all receiving ACE-I/ARB plus SGLT2 inhibitors) from Cairo University outpatient clinics. eGFR, ACR, HbA1c, lipids, electrolytes, and blood pressure were assessed at baseline and one year. Percent changes in eGFR and ACR were calculated and the Kidney Failure Risk Equation estimated 2- and 5-year risk of progressing to end stage kidney disease. Multivariable linear regression identified independent predictors of renal outcome changes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged ≥18 years with type 2 DM
  • •Evident diabetic kidney disease
  • •Recorded ABO blood group phenotypes
  • •Receiving Angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARBs) in addition Sodium-glucose cotransporter 2 inhibitor (SGLT2i) as part of their ongoing therapy prior to enrolment.

排除标准

  • •Pre-existed glomerular diseases or any other primary kidney disorder,
  • •Active urinary sediment
  • •Type 1 diabetes mellitus
  • •Gestational diabetes
  • •History of kidney transplantation
  • •Documented episode of acute kidney injury,
  • •Family history of non-diabetic forms of kidney disease
  • •>30% declines in eGFR after initiation of RAAS inhibitors

研究组 & 干预措施

A Rh+

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

B Rh -

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

B Rh +

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

O Rh -

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

O Rh +

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

AB Rh -

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

AB Rh +

ABO Rh subgroup

干预措施: Laboratory measurements: eGFR, ACR, HbA1c, total cholesterol, triglycerides, sodium, potassium (Diagnostic Test)

结局指标

主要结局

the progression or therapeutic response of diabetic kidney disease

时间窗: 12 months

assessed by the magnitude of percentage change in ACR and percentage change in eGFR across ABO blood groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Farouk

Dr

Cairo University

研究点 (1)

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