Nephropathy, DiabeticDEL1-DNNCT07749664
DEL-1 and Thromboxane A2 in Diabetic Nephropathy Patients
An observational study of Nephropathy, Diabetic, run by Aswan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nephropathy, Diabetic
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- - 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.
About this study
Official title: Developmental Endothelial Locus-1 Serum Level and Its Relation With Thromboxane A2 and Platelet Count in Patients With Diabetic Nephropathy
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.
Read more
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
- Being tested
- No intervention
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is applied. This is an observational study involving clinical assessment and blood sample collection for laboratory analysis only.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy individuals without diabetes or kidney disease. Receives: Other: No intervention | |
| Patients | Patients diagnosed with diabetic nephropathy. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephropathy, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Muhammed Abdelfattah Seleem, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749664
- Sponsor's protocol ID
- DEL1-DN-2025
- Other IDs
- ASWU-MD-2025-DEL1
- Acronym
- DEL1-DN
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Endothelial Locus-1 Serum Level and Its Relation With Thromboxane A2 and Platelet Count in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07749664
- Acronym / sponsor ID
- DEL1-DN / DEL1-DN-2025
- Conditions
- Nephropathy, Diabetic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: No interventionHealthy individuals without diabetes or kidney disease. |
| Patients | – | Other: No interventionPatients diagnosed with diabetic nephropathy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention is applied. This is an observational study involving clinical assessment and blood sample collection for laboratory analysis only. | Other | Control, Patients |
Primary outcome
Serum level of Developmental Endothelial Locus-1 (DEL-1). Time Frame: Baseline
Time frame: Baseline
Measurement of serum DEL-1 levels in patients with diabetic nephropathy compared with healthy controls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephropathy, Diabetic, run by Aswan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of Developmental Endothelial Locus-1 (DEL-1). Time Frame: Baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.