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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetic Kidney Disease, Type2 Diabetes

Intervention / Treatment
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* Other: no interventions required.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Group 1, Diabetic patients): age ≥ 18 years and ≤ 75 years male or female patients with type 2 diabetes treated with life style modification only or any OAD or insulin BMI ≥ 20 e ≤ 40 Kg/m2 patients able to consent Exclusion Criteria (Group 1, Diabetic patients): personal history of current or previous cancer or chemotherapy in the past 5 years personal history of alcohol and/or drugs abuse in the previous 3 months pregnancy Inclusion Criteria (Group 2, Non-diabetic patients): age ≥ 18 years and ≤ 75 years BMI ≥ 20 e ≤ 40 Kg/m2 patients able to consent Exclusion Criteria (Group 2, Non-diabetic patients): diagnosis of type 2 or type 1 diabetes personal history of current or previous cancer or chemotherapy in the past 5 years personal history of alcohol and/or drugs abuse in the previous 3 months pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Type2 Diabetes<br>200 patients with type 2 diabetes consecutively enrolled among those referring to our Diabetes outpatient clinic. | Other: no interventions required.<br>* The study does not require any interventions.<br>|
| Patients without Type2 Diabetes<br>100 patients without diabetes among those referring to our outpatient clinic most of them affected by hypercholesterolemia, obesity or CV disease. | Other: no interventions required.<br>* The study does not require any interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum expression of miR-192 | Levels of miR-192 will be assessed on serum and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio). | Each patients will be assessed at baseline. | 
| Serum expression of miR-25 | Levels of miR-25 will be assessed on serum and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio). | Each patients will be assessed at baseline. | 
| Urine expression of miR-192 | Levels of miR-192 will be assessed on urine and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio). | Each patients will be assessed at baseline. | 
| Urine expression of miR-25 | Levels of miR-25 will be assessed on urine and will be related to glomerular filtration rate and presence or absence of albuminuria (expressed as albumine:creatinine ratio). | Each patients will be assessed at baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DKD, miRNA-25, miRNA-192