Clinical trial NCT04176276: Determining Serum and Urinary Levels of miRNA 192 and miRNA 25 in Patients With and Without Type 2 Diabetes.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Kidney Disease
Type2 Diabetes
Keywords: DKD
miRNA-25
miRNA-192
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will consecutively enrolled 300 patients (200 patients with type 2 diabetes and 100 patients without diabetes) among those referring to the Departiment of Diabetes and Metabolic disease, Santa Chiara Hospital, Pisa.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum expression of miR-192
timeFrame: Each patients will be assessed at baseline.
measure: Serum expression of miR-25
timeFrame: Each patients will be assessed at baseline.
measure: Urine expression of miR-192
timeFrame: Each patients will be assessed at baseline.
measure: Urine expression of miR-25
timeFrame: Each patients will be assessed at baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
affiliation: University of Pisa
name: Anna Solini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: