Assessment of Urinary Uromodulin and the Corresponding Gene Expression as a Biomarker of Diabetic Nephropathy

NCT05695573 | Completed

• 1 other identifier: DN UMOD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Detecting diabetes-related kidney diseases early is crucial to prevent end-stage renal disease (ESRD). Existing biomarkers' specificity and sensitivity vary, emphasizing the need for novel markers. This research assesses urinary uromodulin levels and its gene expression, aiming to identify a potential marker for early diabetic nephropathy (DN) detection in type 2 diabetes patients. Uromodulin, encoded by the UMOD gene, is expressed mainly in the thick ascending limb of Henle's loop epithelial cells, making it a promising candidate for early DN detection and progression towards ESRD, potentially reducing chronic kidney disease prevalence.

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (2)

• Determination the level of urinary uromodulin as a potential biomarker for early prediction of DN

  Evaluate the level of urinary 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

  June, 2022

• Determine the urinary exosomal UMODmRNA gene expression

  Isolation of urinary exosomes and extraction the UMOD mRNA from these exosoms and determine the fold change of the exosomal UMOD mRNA between the diabetic groups and control group and correlate it with the urinary uromodulin level and other kidney biomarker

  June, 2022

Study Arms (4)

Controlgroup

25 healthy volunteer as a control

Diagnostic Test: ACR, fasting, postprandial blood glucose ,HbA1c, creatinine, cystatin-C, BUN, Na, K , lipid profile

diabetic patients with normoalbuminuria

Consisted of 25 type 2 diabetic patients with normoalbuminuria (levels \<30 mg/g creatinine)

Diagnostic Test: ACR, fasting, postprandial blood glucose ,HbA1c, creatinine, cystatin-C, BUN, Na, K , lipid profile

diabetic patients with microalbuminuria

Consisted of 25 type 2 diabetic patients with microalbuminuria (between 30-300 mg/g creatinine).

Diagnostic Test: ACR, fasting, postprandial blood glucose ,HbA1c, creatinine, cystatin-C, BUN, Na, K , lipid profile

diabetic patients with macrolbuminuria

Consisted of 25 type 2 diabetic patients with macroalbuminuria (levels \>300 mg/g creatinine)

Diagnostic Test: ACR, fasting, postprandial blood glucose ,HbA1c, creatinine, cystatin-C, BUN, Na, K , lipid profile

Interventions

ACR, fasting, postprandial blood glucose ,HbA1c, creatinine, cystatin-C, BUN, Na, K , lipid profile DIAGNOSTIC_TEST

Use the ACR to divide diabetic patients to 3groups not normoalbuminuria, microalbuminuria, macroalbuminuria to evaluate the urinary uromodulin level and its exosomal umod mRNA as a potential biomarker of Diabetic nephropathy diagnosis

Controlgroup; diabetic patients with macrolbuminuria; diabetic patients with microalbuminuria; diabetic patients with normoalbuminuria

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients were selected from those admitted to the Internal Medicine Department and outpatients of Tanta University Hospital

You may qualify if:

• Type 2 diabetic patients with not no album in ur is, micoalbuminuria and macroalbuminuria

Sponsors & Collaborators

• Tanta University: lead
• Ain Shams University: collaborator

Study Sites (1)

Tanta university hospital, faculty of science, tanta university

Tanta, Al Gharbia, 31515, Egypt

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples: first morning samples were collected 3ml for ACR 15ml was stored at -80 ℃ until the time of exosome isolation 6ml of peripheral venous blood were collected 2ml of venous blood was collected in an EDTA vacutainer tube for determination of HbA1c. 1ml of venous blood was drawn from each subject 2hrs after meal for postprandial

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Blood Urea Nitrogen

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Kidney Function Tests; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Tarek M mohamed, prof

  Faculty of science, tanta university

  STUDY DIRECTOR

• Eman M Abd elAzeem, prof

  faculty of science, Ain shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tanta, Egypt

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: July 5, 2019
• Primary Completion: April 28, 2022
• Study Completion: June 1, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)