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

NCT ID: NCT04176276

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-03-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with Type2 Diabetes

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

no interventions required.

Intervention Type: OTHER

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.

no interventions required.

Intervention Type: OTHER

The study does not require any interventions.

Interventions

no interventions required.

The study does not require any interventions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• age ≥ 18 years and ≤ 75 years
• BMI ≥ 20 e ≤ 40 Kg/m2
• patients able to consent

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Anna Solini

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Solini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

University of Pisa

Pisa, , Italy

Countries

Italy

Other Identifiers

AS0004

Identifier Type: -

Identifier Source: org_study_id