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Not yet recruitingNCT07919795Updated Nov 5, 2026

Beta-2-Trace Protein in Diabetic Nephropathy

An observational study in Diabetic Nephropathy Type 2 and Type 2 Diabetes Mellitus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Assiut University · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetic Nephropathy Type 2
  • Type 2 Diabetes Mellitus

Keywords

  • Beta-2-trace protein
  • Diabetic nephropathy
  • Type 2 diabetes
  • eGFR
  • Assiut
03

In context

Diabetes Mellitus, Type 2

9,618 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,340 are open to participants now.

This study's planned enrollment of 80 is below the median of 300 across 1,628 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Assiut University is the lead sponsor of 5,071 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult patients aged 18 years or older with diabetic nephropathy and age-matched healthy controls attending Assiut University Hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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

Exclusion criteria

Exclusion Criteria:

  • - Age below 18 years
  • Acute kidney injury
  • Type 1 diabetes mellitus
  • Malignancy
  • Cardiovascular diseases
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Diabetic Nephropathy

    Adult patients with type 2 diabetes mellitus and documented diabetic nephropathy.

  • Healthy Controls

    Apparently healthy adults without diabetes or kidney disease.

06

What researchers measure

Primary outcomes

  1. Serum beta-2-trace protein level

    Mean serum beta-2-trace protein concentration measured by enzyme-linked immunosorbent assay.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. Serum creatinine

    Mean serum creatinine level in milligrams per deciliter.

    Time frame: Baseline

  3. Urine albumin-to-creatinine ratio

    Mean urine albumin-to-creatinine ratio in milligrams per gram.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07919795
Lead sponsor
Assiut University
Responsible party
Salma Ramadan Mahmoud Abdelwarth (Resident Physician, Department of Clinical Pathology, Assiut University) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Nov 10, 2027 (estimated)
Completion
Feb 25, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Salma R Mahmoud, Resident
Contact
salma.18313305@med.aun.edu.eg
01117364896
Dina A Mohammed, prof
study chair · Clinical pathology Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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