Diabetic NephropathyNCT07173686
Evaluating The Roles of Novel Inflammatory Markers Compared to MCP-1 in Type 2 Diabetic Nephropathy
An observational study of Diabetic Nephropathy, run by Assiut University.
Trial summary
Diabetic kidney disease (DKD) is one of the most common microvascular complications of type 2 diabetes mellitus (T2DM), affecting up to 40% of diabetic patients and accounting for the leading cause of end-stage renal disease worldwide [1]. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult aged 18-80 years, both genders with clear history of T2DM
Who may be able to join
- Adult aged 18-80 years, both genders.
- clear history of T2DM
Who cannot join
- Kidney disease caused by any other causes
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 - m2
- Existing obvious infection
- Acute stage of cardiovascular or cerebrovascular diseases
- Acute complications of diabetes recently (such as diabetic ketoacidosis, et al.)
- Associated malignant tumors
- Hematological system, and autoimmune system diseases
About this study
Diabetic kidney disease (DKD) is one of the most common microvascular complications of type 2 diabetes mellitus (T2DM), affecting up to 40% of diabetic patients and accounting for the leading cause of end-stage renal disease worldwide [1]. The progression of DKD involves multiple mechanisms, including oxidative stress, endothelial dysfunction, and most importantly, chronic inflammation [2].
Systemic inflammation plays a central role in renal injury by promoting glomerular and tubulointerstitial damage. the neutrophil-to-lymphocyte ratio (NLR) and systemic inflammatory index (SII) has emerged as a readily accessible markers of subclinical inflammation. Elevated NLR and SII levels have been significantly associated with increased urinary albumin excretion and decreased estimated glomerular filtration rate (eGFR) in T2DM patients [3]. It was demonstrated that patients in the highest NLR tertile had a higher prevalence of DKD, independent of confounders [4].
Read more
High-sensitivity C-reactive protein (hsCRP), is widely used to evaluate systemic inflammation. Recent studies have shown a strong association between elevated hsCRP levels and DKD development [5].Some studies provided genetic evidence supporting a causal relationship between higher hsCRP and diabetic nephropathy [6].
Monocyte chemoattractant protein-1 (MCP-1) is a chemokine involved in monocyte recruitment to inflamed renal tissues. Elevated serum and urinary MCP-1 levels have been found to predict microalbuminuria and eGFR decline in T2DM patients [7,8].
Identifying these markers may help in early diagnosis, risk stratification, and monitoring progression of DKD.
- Conditions
- Diabetic Nephropathy
- Medical subject headings
- 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 |
|---|---|---|
| Group 1 | diabetic patients without diabetic nephropathy (albumin/creatinine ratio: < 30 mg alb/gm creatinine ) | |
| Group2 | diabetic patients with first stage diabetic nephropathy ( albumin/creatinine ratio: 30-300 mg alb/gm creatinine) | |
| Group 3 | diabetic patients with second stage diabetic nephropathy (albumin/creatinine ratio >300 mg alb/gm creatinine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCP-1 level
Assessment the role of MCP-1 in early detection of diabetic nephropathy.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naira Ali Mohammed Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173686
- Sponsor's protocol ID
- MCP-1 DM 2
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Roles of Novel Inflammatory Markers Compared to MCP-1 in Type 2 Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07173686
- Acronym / sponsor ID
- MCP-1 DM 2
- Conditions
- Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 Sep 2025 (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 kidney disease (DKD) is one of the most common microvascular complications of type 2 diabetes mellitus (T2DM), affecting up to 40% of diabetic patients and accounting for the leading cause of end-stage renal disease worldwide [1]. The progression of DKD involves multiple mechanisms, including oxidative stress, endothelial dysfunction, and most importantly, chronic inflammation [2].
Systemic inflammation plays a central role in renal injury by promoting glomerular and tubulointerstitial damage. the neutrophil-to-lymphocyte ratio (NLR) and systemic inflammatory index (SII) has emerged as a readily accessible markers of subclinical inflammation. Elevated NLR and SII levels have been significantly associated with increased urinary albumin excretion and decreased estimated glomerular filtration rate (eGFR) in T2DM patients [3]. It was demonstrated that patients in the highest NLR tertile had a higher prevalence of DKD, independent of confounders [4].
High-sensitivity C-reactive protein (hsCRP), is widely used to evaluate systemic inflammation. Recent studies have shown a strong association between elevated hsCRP levels and DKD development [5].Some studies provided genetic evidence supporting a causal relationship between higher hsCRP and diabetic nephropathy [6].
Monocyte chemoattractant protein-1 (MCP-1) is a chemokine involved in monocyte recruitment to inflamed renal tissues. Elevated serum and urinary MCP-1 levels have been found to predict microalbuminuria and eGFR decline in T2DM patients [7,8].
Identifying these markers may help in early diagnosis, risk stratification, and monitoring progression of DKD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –diabetic patients without diabetic nephropathy (albumin/creatinine ratio: < 30 mg alb/gm creatinine ) |
| Group2 | – | –diabetic patients with first stage diabetic nephropathy ( albumin/creatinine ratio: 30-300 mg alb/gm creatinine) |
| Group 3 | – | –diabetic patients with second stage diabetic nephropathy (albumin/creatinine ratio >300 mg alb/gm creatinine) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult aged 18-80 years, both genders with clear history of T2DM
Key inclusion criteria (2 listed)
- Adult aged 18-80 years, both genders.
- clear history of T2DM
Key exclusion criteria (7 listed)
- Kidney disease caused by any other causes
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 - m2
- Existing obvious infection
- Acute stage of cardiovascular or cerebrovascular diseases
- Acute complications of diabetes recently (such as diabetic ketoacidosis, et al.)
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
MCP-1 level
Time frame: baseline
Assessment the role of MCP-1 in early detection of diabetic nephropathy.
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 15 Sep 2025.
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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 Diabetic Nephropathy, 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 2 inclusion and 7 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 15 Sep 2025. 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?
MCP-1 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 15 Sep 2025.