Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Introduction: Diabetes mellitus (DM) is a metabolic disorder characterized by elevated blood glucose levels resulting from deficiencies in insulin secretion, insulin action, or both. Prolonged hyperglycemia associated with diabetes can lead to lasting damage and dysfunction in various organs, including the eyes, kidneys, nerves, heart, and blood vessels (American Diabetes Association, 2008). Among the complications of diabetes, diabetic nephropathy (DN) stands out as a significant contributor to chronic kidney disease (CKD) (Macisaac et al., 2014). Pathophysiologically, DN progresses from an early phase featuring glomerular hypertrophy, hyperfiltration, and microalbuminuria to an advanced phase marked by progressive glomerulosclerosis, increased urinary albumin excretion (UAE), and impaired renal function (Schrijvers et al., 2004). Traditionally, DN severity is assessed by measuring urine albumin levels, with persistent microalbuminuria (30-300 mg/24 hr) or macroalbuminuria (>300 mg/24 hr) serving as markers and predictors of DN and its progression to end-stage renal disease (Adler et al., 2003). Current practices in biomarker use for DN diagnosis show conflicting results regarding sensitivity and specificity in recent studies. Therefore, it is imperative to identify novel biomarkers for early DN detection and progression to reduce the prevalence of chronic kidney diseases in the population (Carole et al., 2017). Uromodulin, also known as Tamm-Horsfall protein, is an 85 kDa glycoprotein normally secreted by epithelial cells lining the thick ascending limb (TAL) of Henle's loop and early distal tubule. It is released through proteolytic cleavage of glycosylphosphatidylinositol (GPI)-anchored protein, primarily localized to the apical plasma membrane. Uromodulin levels undergo significant changes in urinary excretion during pathological conditions, making it a valuable marker for renal disease ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05695573
Study type Observational
Source Tanta University
Contact
Status Completed
Phase
Start date July 5, 2019
Completion date June 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04562025 - Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy N/A
Not yet recruiting NCT03658317 - Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy N/A
Recruiting NCT02501772 - The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy N/A
Completed NCT02251067 - Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients Phase 2
Completed NCT02276196 - Effect of LIXIsenatide on the Renal System Phase 4
Completed NCT02829177 - Microalbuminuria and Allopurinol in Type 1 Diabetes Phase 4
Completed NCT01440257 - A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria Phase 2
Active, not recruiting NCT01273675 - An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy N/A
Terminated NCT01129557 - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease Phase 4
Completed NCT00317954 - Spironolactone in Diabetic Nephropathy Phase 4
Active, not recruiting NCT02237352 - Mechanisms of Diabetic Nephropathy in Ecuador
Not yet recruiting NCT05061459 - The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy
Completed NCT01935167 - To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy Phase 2
Recruiting NCT01673204 - Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy Phase 4
Completed NCT01726816 - Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy Phase 2
Recruiting NCT01458158 - Matrix Metalloproteinases in Atherosclerosis of Chronic Kidney Disease N/A
Completed NCT01476501 - Vitamin D Supplementation in Diabetic Nephropathy Phase 2
Completed NCT01447147 - A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy Phase 2
Completed NCT01003236 - Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy Phase 2
Completed NCT00535925 - Nephropathy In Type 2 Diabetes and Cardio-renal Events Phase 4