NCT06596863

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,774

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

29 days

First QC Date

September 11, 2024

Last Update Submit

September 14, 2024

Conditions

Keywords

DKD, urimodulin

Outcome Measures

Primary Outcomes (1)

  • 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

    may, 2024

Study Arms (2)

Control group

Included 862 healthy subjects as control group

Diagnostic Test: The association of serum uromodulin with DNDiagnostic 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

Diagnostic Test: The association of serum uromodulin with DNDiagnostic 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

Interventions

Meta analysis of association of serum uromodulin with DKD

Control groupDKD group

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

Control groupDKD group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta Yniversity

Tanta, Yes, 31511, Egypt

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Glomerular Filtration Rate

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Kidney Function TestsDiagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr of Biochemistry

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

May 1, 2024

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations