DEL-1 and Thromboxane A2 in Diabetic Nephropathy Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAswan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

- Patients with known hepatic disease.

Patients with significant cardiovascular disease.

Patients with malignancy.

Patients who have undergone recent surgery.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control1 intervention
Group B: Patients1 intervention

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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