DEL-1 and Thromboxane A2 in Diabetic Nephropathy Patients

NCT07749664 | Not Yet Recruiting

• 2 other identifiers: DEL1-DN-2025ASWU-MD-2025-DEL1
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetic nephropathy is one of the most common microvascular complications of diabetes mellitus and a leading cause of chronic kidney disease. Inflammation and platelet activation are believed to play a significant role in its pathogenesis and progression. Developmental endothelial locus-1 (DEL-1) is an anti-inflammatory protein that regulates leukocyte adhesion and endothelial function, while thromboxane A2 is a marker of platelet activation and contributes to vascular dysfunction. This study aims to evaluate serum levels of DEL-1 and thromboxane A2, and their relationship with platelet count in patients with diabetic nephropathy. Additionally, the study investigates the correlation between these biomarkers and disease severity. This observational cross-sectional study will be conducted on 80 participants, including patients with diabetic nephropathy and healthy controls, to explore the potential role of these biomarkers in disease progression and their possible use as diagnostic or prognostic indicators.

Conditions

Nephropathy, Diabetic

Outcome Measures

Primary Outcomes (1)

• Serum level of Developmental Endothelial Locus-1 (DEL-1). Time Frame: Baseline

  Measurement of serum DEL-1 levels in patients with diabetic nephropathy compared with healthy controls.

  Baseline

Study Arms (2)

Control

Healthy individuals without diabetes or kidney disease.

Other: No intervention

Patients

Patients diagnosed with diabetic nephropathy.

Other: No intervention

Interventions

No intervention OTHER

No intervention is applied. This is an observational study involving clinical assessment and blood sample collection for laboratory analysis only.

Control; Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult participants aged 18 to 70 years, recruited from Aswan University Hospital. The study will consist of patients diagnosed with diabetic nephropathy based on clinical and laboratory criteria, in addition to a group of age- and sex-matched healthy controls. Patients with diabetic nephropathy will be enrolled regardless of disease stage to allow assessment of biomarker variation across different levels of disease severity. All participants will undergo clinical evaluation and laboratory investigations. Participants with significant comorbid conditions that may affect inflammatory status or platelet function will be excluded to minimize confounding factors.

You may qualify if:

• Adult patients aged between 18 and 70 years.
• Patients diagnosed with diabetic nephropathy based on clinical and laboratory findings.
• Patients undergoing evaluation or follow-up for diabetic kidney disease.
• Ability and willingness to provide informed consent.

You may not qualify if:

• \- Patients with known hepatic disease.
• Patients with significant cardiovascular disease.
• Patients with malignancy.
• Patients who have undergone recent surgery.
• Patients with known hematological disorders or hypercoagulable states.
• Patients receiving medications that significantly affect platelet function.

Sponsors & Collaborators

• Aswan University: lead

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Medical Physiology

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share