NCT04176276

Determining Serum and Urinary Levels of miRNA 192 and miRNA 25 in Patients With and Without Type 2 Diabetes.

Association Between Urinary and Serum Levels of miRNA 192 and miRNA 25 and Glomerular Filtration and Albuminuria in Patients With and Without Type 2 Diabetes.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Diabetes kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) in western countries and its incidence is worryingly increasing worldwide. Cardiovascular disease shows a continuous relationship with declining of renal function in type 2 diabetes patients. Moreover, there is a strong evidence of all-cause mortality risk excess even in patients with early stages kidney disease. MicroRNA (miRNA) are small non-coding RNA molecules, containing 21-25 nucleotides, that modulate post-transcriptional gene expressions. In the past years many human miRNAs involved in the pathogenesis of renal disease have been discovered, such as miR-192, miR-194, miR-204 and miR-25. Among these, miR-192 and miR-25, are receiving greater attention while it seems that they play a role in glomerulosclerosis and renal fibrosis. However too few data are available in large publish trials among patients with renal impairment and the role of serum and urinary levels of miR-192 and miR-25 in people with preserved renal function remain unclear. To evaluate the association between serum and urinary expression of miR-192 and miR-25 and renal function (according to different extent of renal impairment) in patients with or without type 2 diabetes.

Detailed description

The day of the study patients undergo a routine clinical evaluation. Whole blood samples are collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin) and determination of serum miR-192 and miR-25. Two urine samples will be also collected to assess aliquots of 200 μl each (frozen at -80°C until required for quantitation) for determination of albumin:creatinine ratio and urine expression of miR-192 and miR-25.

Conditions

• Diabetic Kidney Disease
• Type2 Diabetes

Interventions

Type	Name	Description
OTHER	no interventions required.	The study does not require any interventions.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-31
• Completion: 2020-03-01
• First posted: 2019-11-25
• Last updated: 2020-06-05

Locations

1 site across 1 country: Italy