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临床试验/NCT07476248
NCT07476248尚未招募不适用

The Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to High-density Lipoprotein Cholesterol (HDL-C) Ratio (NHHR) and Its Association With Occurrence of Diabetic Nephropathy in Patients With Diabetes Mellitus

Assiut University0 个研究点目标入组 84 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
84
主要终点
Association between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and the presence of diabetic nephropathy.

研究概览

简要总结

The study aims to examine the relationship between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and CKD in patients with DM.

详细描述

The study will include adult participants recruited from outpatient clinics and inpatient departments. Participants will be classified into the following groups:

  1. Diabetes Mellitus without Diabetic Nephropathy (DM group) :

Patients with diabetes mellitus who have no evidence of diabetic nephropathy will be defined by a normal urinary albumin-to-creatinine ratio (UACR) and preserved renal function. 2. Diabetic Nephropathy group (DN group) :

Patients with diabetes mellitus and diabetic nephropathy will be defined by the presence of elevated UACR and/or impaired renal function as assessed by estimated glomerular filtration rate (eGFR).

Subgroup Analysis :

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥18 years
  • Diagnosed cases of diabetes mellitus (Type 1 or Type 2), with or without diabetic nephropathy
  • Willingness to participate and provide informed consent

排除标准

  • Known non-diabetic causes of chronic kidney disease
  • Acute kidney injury
  • Chronic inflammatory or autoimmune diseases
  • Current use of medications known to significantly alter lipid metabolism (other than standard lipid-lowering therapy, if applicable)
  • End-stage renal disease patients on dialysis

研究组 & 干预措施

Diabetes Mellitus without Diabetic Nephropathy (DM group)

Patients with diabetes mellitus who have no evidence of diabetic nephropathy will be defined by a normal urinary albumin-to-creatinine ratio (UACR) and preserved renal function.

Diabetic Nephropathy group (DN group)

Patients with diabetes mellitus and diabetic nephropathy will be defined by the presence of elevated UACR and/or impaired renal function as assessed by estimated glomerular filtration rate (eGFR).

And within the diabetic nephropathy group, further subgroup analyses will be performed to assess differences in NHHR according to:

  1. Type of diabetes (Type 1 vs. Type 2 diabetes mellitus)
  2. Stages of chronic kidney disease (CKD) are classified based on KDIGO definitions of CKD based on estimated GFR and albuminuria.

结局指标

主要结局

Association between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and the presence of diabetic nephropathy.

时间窗: At baseline

Diabetic nephropathy defined as urinary albumin-to-creatinine ratio (UACR) ≥30 mg/g and/or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², measured at enrollment. The non-HDL cholesterol to HDL cholesterol ratio (NHHR) will be calculated from fasting lipid profile obtained at the same visit.

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

Ragaey Edward Riad

Resident physician

Assiut University

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