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

Sponsor

University of Pisa (Other)

Overall Status

Completed

CT.gov ID

NCT04176276

Collaborator

(none)

300

Enrollment

Location

Actual Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Kidney Disease Type2 Diabetes	Other: no interventions required.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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.

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients with Type2 Diabetes 200 patients with type 2 diabetes consecutively enrolled among those referring to our Diabetes outpatient clinic.	Other: no interventions required. The study does not require any interventions.
Patients without Type2 Diabetes 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. The study does not require any interventions.

Arm

Intervention/Treatment

Patients with Type2 Diabetes

200 patients with type 2 diabetes consecutively enrolled among those referring to our Diabetes outpatient clinic.

Other: no interventions required.

The study does not require any interventions.

Patients without Type2 Diabetes

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.

The study does not require any interventions.

Outcome Measures

Primary Outcome Measures

Serum expression of miR-192 [Each patients will be assessed at baseline.]
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).
Serum expression of miR-25 [Each patients will be assessed at baseline.]
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).
Urine expression of miR-192 [Each patients will be assessed at baseline.]
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).
Urine expression of miR-25 [Each patients will be assessed at baseline.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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