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

Type2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176276
• Other study ID #: AS0004
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2020
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Type2 Diabetes

Intervention

Other:
• no interventions required.
The study does not require any interventions.

Locations

Country	Name	City	State
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.