Diabetic NephropathiesNCT06596863
Serum Uromodulin and DN Systematic Review and Meta Analysis
An observational study of Diabetic Nephropathies, run by Tanta University at 1 site in Egypt.
Trial summary
Several studies have investigated the association between the changes of serum uromodulin and diabetic nephropathy (DN). However, the results are still controversial. Hence, this meta-analysis aimed to evaluate the association of uromodulin with DN. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- The association of serum uromodulin with DN and The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN
- How many people
- 1,774 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The systematic search strategy retrieved 275 publications by the 4 databases (PubMed 76, Cochrane Library 11, Web of Science 107, and Scopus 81). 144 studies remained after exclusion the duplicates. After screening title and abstract 135 studies were excluded. 9 studies remained for full text and data reviewing. 4 studies of them were excluded as they didn't meet the eligibility criteria. In addition, 1 study was retrieved by manual search from Google Scholar. Finally, 6 articles were included [20-25]. The selected studies included 1774 participant
Who may be able to join
- Studies were included if they met the following criteria:
- serum level of uromodulin was determined;
- the samples were enrolled from diabetic patients;
- mean ± SD was reported for uromodulin between patients with and without DN;
- the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN was determined
Who cannot join
- Studies were excluded according to the following criteria:
- duplicate studies;
- review articles;
- non original research articles;
- studies with insufficient data to extract;
- non-human research;
- studies that determined urine level of uromodulin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Serum Uromodulin and DKD a Systematic Review and Meta Analysis
Several studies have investigated the association between the changes of serum uromodulin and diabetic nephropathy (DN). However, the results are still controversial. Hence, this meta-analysis aimed to evaluate the association of uromodulin with DN.
- Conditions
- Diabetic Nephropathies
- Being tested
- The association of serum uromodulin with DN, The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN
- Keywords
- DKD, urimodulin
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The association of serum uromodulin with DNDiagnostic test
Meta analysis of association of serum uromodulin with DKD
The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DNDiagnostic test
DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN
| Study group | Role | What they receive |
|---|---|---|
| Control group | Included 862 healthy subjects as control group Receives: Diagnostic Test: The association of serum uromodulin with DN; Diagnostic Test: The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN | |
| DKD group | Included 912 patients with DN Receives: Diagnostic Test: The association of serum uromodulin with DN; Diagnostic Test: The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of serum uromodulin with DKD: asystematic review and meta analysis
Evaluate the meta analysis of association of serum uromodulin in the 3 diabetic group comparing with each other and compare them to the control group and correlate these results with other kidney biomarker
Measured: may, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Retrospective
- Enrolment
- 1,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Shaimaa Ibrahim Barr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596863
- Sponsor's protocol ID
- DKD serum uromodulin
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum Uromodulin and DKD a Systematic Review and Meta Analysis
- ClinicalTrials.gov ID
- NCT06596863
- Acronym / sponsor ID
- DKD serum uromodulin
- Conditions
- Diabetic Nephropathies
- Keywords
- DKD, urimodulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,774 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Several studies have investigated the association between the changes of serum uromodulin and diabetic nephropathy (DN). However, the results are still controversial. Hence, this meta-analysis aimed to evaluate the association of uromodulin with DN.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: The association of serum uromodulin with DN, Diagnostic Test: The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DNIncluded 862 healthy subjects as control group |
| DKD group | – | Diagnostic Test: The association of serum uromodulin with DN, Diagnostic Test: The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DNIncluded 912 patients with DN |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The systematic search strategy retrieved 275 publications by the 4 databases (PubMed 76, Cochrane Library 11, Web of Science 107, and Scopus 81). 144 studies remained after exclusion the duplicates. After screening title and abstract 135 studies were excluded. 9 studies remained for full text and data reviewing. 4 studies of them were excluded as they didn't meet the eligibility criteria. In addition, 1 study was retrieved by manual search from Google Scholar. Finally, 6 articles were included [20-25]. The selected studies included 1774 participant
Key inclusion criteria (5 listed)
- Studies were included if they met the following criteria:
Key exclusion criteria (7 listed)
- Studies were excluded according to the following criteria:
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 |
|---|---|---|
| The association of serum uromodulin with DNMeta analysis of association of serum uromodulin with DKD | Diagnostic test | Control group, DKD group |
| The DN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DNDN patients were divided according to the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN | Diagnostic test | Control group, DKD group |
Primary outcome
Association of serum uromodulin with DKD: asystematic review and meta analysis
Time frame: may, 2024
Evaluate the meta analysis of association of serum uromodulin in the 3 diabetic group comparing with each other and compare them to the control group and correlate these results with other kidney biomarker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, run by Tanta University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association of serum uromodulin with DKD: asystematic review and meta analysis (time frame: may, 2024). 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 19 Sep 2024.