Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA

NCT ID: NCT07055984

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-28

Study Completion Date

2029-04-28

Brief Summary

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The study aims to improve the prediction and early detection of post-transplant diabetes mellitus (PTDM) in kidney transplant recipients. The investigators are investigating whether specific microRNA profiles measured 3 months after transplantation can reliably predict the development of PTDM within the following one to two years.

Additionally, the investigators are evaluating how traditional risk factors-such as age, immunosuppressive therapy, obesity, and infections like CMV-interact with these microRNA markers.

The ultimate goal of this research is to identify early indicators of blood sugar issues, enabling timely interventions to improve health outcomes and personalize patient care after kidney transplantation.

Detailed Description

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Conditions

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Diabetes Mellitus Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients after primary kidney transplantation without type 1 or type 2 diabetes melltus

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing kidney transplantation.
* Absence of pre-existing type 1 or type 2 diabetes mellitus.
* Willingness to provide informed consent and comply with study procedures.

Exclusion Criteria

* Pre-existing type 1 or type 2 diabetes mellitus.
* Previous organ transplantation.
* Severe comorbidities that could confound the assessment of PTDM (e.g., pancreatic disease).
* Inability to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Martin

OTHER

Sponsor Role lead

Responsible Party

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Matej Vnucak

Study coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Transplant-nephorlogy department

Martin, , Slovakia

Site Status RECRUITING

University hospital Martin

Martin, , Slovakia

Site Status RECRUITING

Countries

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Slovakia

Central Contacts

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Ivana Dedinska, prof, MD, PhD.

Role: CONTACT

+421 43 4203 920

Facility Contacts

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Ivana Dedinska, prof, MD, PhD.

Role: primary

+421434203184

Ivana Dedinska, prof. MD, PhD.

Role: primary

+421 43 4203 920

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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University hospital Martin

Identifier Type: -

Identifier Source: org_study_id

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