Diabetic Nephropathy Type 2NCT07919795
Beta-2-Trace Protein in Diabetic Nephropathy
An observational study of Diabetic Nephropathy Type 2 and Type 2 Diabetes Mellitus, run by Assiut University.
Trial summary
This cross-sectional study aims to evaluate serum beta-2-trace protein levels in patients with diabetic nephropathy compared with healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 25 Feb 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients aged 18 years or older with diabetic nephropathy and age-matched healthy controls attending Assiut University Hospitals.
Who may be able to join
- - Adult patients aged 18 years or older
- Documented diabetic nephropathy for at least three months (patient group)
- Apparently healthy adults (control group)
- Written informed consent
Who cannot join
- - Age below 18 years
- Acute kidney injury
- Type 1 diabetes mellitus
- Malignancy
- Cardiovascular diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Beta-2-Trace Protein as Early Predictor of Diabetic Nephropathy in Patients With Type II Diabetes Mellitus
This cross-sectional study aims to evaluate serum beta-2-trace protein levels in patients with diabetic nephropathy compared with healthy controls.
Read the detailed description
Diabetic nephropathy is a major complication of type 2 diabetes mellitus. Beta-2-trace protein is a low-molecular-weight glycoprotein that is freely filtered by the glomerulus and has been proposed as a marker of kidney function.
This observational study will measure serum beta-2-trace protein by enzyme-linked immunosorbent assay in adult patients with diabetic nephropathy and healthy controls, and will also assess estimated glomerular filtration rate and other routine laboratory parameters.
- Keywords
- Beta-2-trace protein, Diabetic nephropathy, Type 2 diabetes, eGFR, Assiut
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Nephropathy | Adult patients with type 2 diabetes mellitus and documented diabetic nephropathy. | |
| Healthy Controls | Apparently healthy adults without diabetes or kidney disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum beta-2-trace protein level
Mean serum beta-2-trace protein concentration measured by enzyme-linked immunosorbent assay.
Measured: Baseline
Secondary outcomes (3)
Estimated glomerular filtration rate
Mean estimated glomerular filtration rate calculated by the CKD-EPI 2021 equation in milliliters per minute per 1.73 square meters.
Measured: Baseline
Serum creatinine
Mean serum creatinine level in milligrams per deciliter.
Measured: Baseline
Urine albumin-to-creatinine ratio
Mean urine albumin-to-creatinine ratio in milligrams per gram.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion10 Nov 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Ramadan Mahmoud Abdelwarth, Assiut University
- Investigators
- Dina A Mohammed, prof, Study chair, Clinical pathology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919795
- Sponsor's protocol ID
- BTP-DN-Assiut-2026
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Beta-2-Trace Protein as Early Predictor of Diabetic Nephropathy in Patients With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07919795
- Acronym / sponsor ID
- BTP-DN-Assiut-2026
- Keywords
- Beta-2-trace protein, Diabetic nephropathy, Type 2 diabetes, eGFR, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 5 Nov 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.
This cross-sectional study aims to evaluate serum beta-2-trace protein levels in patients with diabetic nephropathy compared with healthy controls.
Detailed description
Diabetic nephropathy is a major complication of type 2 diabetes mellitus. Beta-2-trace protein is a low-molecular-weight glycoprotein that is freely filtered by the glomerulus and has been proposed as a marker of kidney function.
This observational study will measure serum beta-2-trace protein by enzyme-linked immunosorbent assay in adult patients with diabetic nephropathy and healthy controls, and will also assess estimated glomerular filtration rate and other routine laboratory parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Nephropathy | – | –Adult patients with type 2 diabetes mellitus and documented diabetic nephropathy. |
| Healthy Controls | – | –Apparently healthy adults without diabetes or kidney disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older with diabetic nephropathy and age-matched healthy controls attending Assiut University Hospitals.
Key inclusion criteria (4 listed)
- - Adult patients aged 18 years or older
- Documented diabetic nephropathy for at least three months (patient group)
- Apparently healthy adults (control group)
- Written informed consent
Key exclusion criteria (5 listed)
- - Age below 18 years
- Acute kidney injury
- Type 1 diabetes mellitus
- Malignancy
- Cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum beta-2-trace protein level
Time frame: Baseline
Mean serum beta-2-trace protein concentration measured by enzyme-linked immunosorbent assay.
3 secondary outcomes
Estimated glomerular filtration rate
Time frame: Baseline
Serum creatinine
Time frame: Baseline
Urine albumin-to-creatinine ratio
Time frame: Baseline
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 5 Nov 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.
Dina A Mohammed, prof study chair
Clinical pathology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy Type 2 and Type 2 Diabetes Mellitus, run by Assiut 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 5 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 5 Nov 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?
Contact Salma R Mahmoud, Resident (01117364896, salma.18313305@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum beta-2-trace protein level (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 5 Nov 2026.