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NCT Number: NCT07476248

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

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.

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Key information

About this study

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

  • 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).

Subgroup Analysis :

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

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

Type of the study: Comparative cross-sectional study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ragaey Edward Riad

CONTACT

[email protected]

+20 1206503994

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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