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

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ClinicalTrials.gov Identifier: NCT04176276
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Solini, University of Pisa

Study Description
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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
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
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Study Type : Observational
Estimated 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 : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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).


Biospecimen Retention:   Samples With DNA
Urine, serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176276


Contacts
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Contact: Anna Solini, MD, PhD +39050993482 anna.solini@med.unipi.it
Contact: Anna Solini, MD, PhD

Locations
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Italy
University of Pisa Recruiting
Pisa, Italy, 56125
Contact: Anna Solini, MD, PhD    +39050993482    anna.solini@med.unipi.it   
Sponsors and Collaborators
University of Pisa
Investigators
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Principal Investigator: Anna Solini, MD, PhD University of Pisa
More Information
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Responsible Party: Anna Solini, Associate Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT04176276     History of Changes
Other Study ID Numbers: AS0004
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Solini, University of Pisa:
DKD
miRNA-25
miRNA-192
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications