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

NCT04176276 | Completed

• 1 other identifier: AS0004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease; Type2 Diabetes

Keywords

DKD; miRNA-25; miRNA-192

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Patients with Type2 Diabetes

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

Other: no interventions required.

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.

Interventions

no interventions required. OTHER

The study does not require any interventions.

Patients with Type2 Diabetes; Patients without Type2 Diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56125, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, serum

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Anna Solini, MD, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

IT (1)