Urinary Biomarkers of Renal Injury in Inflammatory Bowel Disease

NCT ID: NCT04282577

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-01

Brief Summary

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The study aims to early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function test focusing on glomerular filtration barrier injury and tubular injury and it's relation to disease activity so precautions could be taken properly to prevent further renal injury later on .

Detailed Description

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Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two principal types of IBD. The prevalence of IBD has been increasing worldwide . Extraintestinal manifestations of IBD are common, occurring in 6% to 47% of patients involving nearly every organ system .

Renal and urinary system involvement are common in IBD patients with incidence varying from 4% to 23% and is greater in patients with more severe and long-standing disease. Apart from secondary complications, such as nephrolithiasis, hydronephrosis and amyloidosis, other disorders have also been reported. Membranous glomerulonephritis, rapidly progressive glomerulonephritis, mesangiocapillary glomerulonephritis, IgA nephropathy, thin basement membrane disease and kidney granuloma found to be connected with IBD. In addition, non-specific morphological changes in the glomeruli of patients with IBD, like podocyte effacement and mesangial deposition of immunoglobulin and complement have been well documented. Cases of interstitial nephritis reported to be attributed to the nephrotoxic effect of aminosalicylates which used in IBD treatment.

Alpha one microglobulin is a relatively small protein that undergoes glomerular filtration followed by reabsorption and catabolism in the proximal tubules. Increased urinary α1-microglobulin concentration therefore provides an index of proximal tubule dysfunction .

Glomerular filtration barrier related protein changes have not been closely investigated in IBD patients . Nephrin is podocyte-associated protein that play key roles in maintaining the structural and functional integrity of the kidney's filtration barrier. The shedding of nephrin reflects compromisation of podocytes' functional and structural integrity.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients with chron's disease

urinary nephrin and alpha one microglobulin

Intervention Type DIAGNOSTIC_TEST

urinary nephrin and alpha one microglobulin are biomarkers of glomerular filtration barrier injury and tubular injury respectively measured by ELISA

patients with ulcerative cholitis

urinary nephrin and alpha one microglobulin

Intervention Type DIAGNOSTIC_TEST

urinary nephrin and alpha one microglobulin are biomarkers of glomerular filtration barrier injury and tubular injury respectively measured by ELISA

Interventions

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urinary nephrin and alpha one microglobulin

urinary nephrin and alpha one microglobulin are biomarkers of glomerular filtration barrier injury and tubular injury respectively measured by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Patients diagnosed to have inflammatory bowel disease (ulcerative colitis or chron's disease )with age more than 18 years and normal kidney function test

Exclusion Criteria

Patients known to have renal disease due to other causes . Diabetic patients . Hypertensive patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Noha Gamal Abdelmalik

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Noha G Abdelmalik

Role: CONTACT

01005509890

Wael A Abbas

Role: CONTACT

01064236064

References

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Akankwasa G, Jianhua L, Guixue C, Changjuan A, Xiaosong Q. Urine markers of podocyte dysfunction: a review of podocalyxin and nephrin in selected glomerular diseases. Biomark Med. 2018 Aug;12(8):927-935. doi: 10.2217/bmm-2018-0152. Epub 2018 Jul 6.

Reference Type BACKGROUND
PMID: 29976076 (View on PubMed)

Chang CJ, Wang PC, Huang TC, Taniguchi A. Change in Renal Glomerular Collagens and Glomerular Filtration Barrier-Related Proteins in a Dextran Sulfate Sodium-Induced Colitis Mouse Model. Int J Mol Sci. 2019 Mar 22;20(6):1458. doi: 10.3390/ijms20061458.

Reference Type BACKGROUND
PMID: 30909435 (View on PubMed)

Other Identifiers

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Kidney in IBD

Identifier Type: -

Identifier Source: org_study_id

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