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NCT Number: NCT04176276

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

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.

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Type2 Diabetes Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa

Pisa, 56125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no interventions required.

Other

The study does not require any interventions.

Primary outcomes

  1. Serum expression of miR-192

    Time frame: 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).

  2. Serum expression of miR-25

    Time frame: 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).

  3. Urine expression of miR-192

    Time frame: 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).

  4. Urine expression of miR-25

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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