Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07055984

Acronym

POD-MIR

Enrollment

130

Registered

2025-07-09

Start date

2025-04-28

Completion date

2029-04-28

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Kidney Transplant

Keywords

post-transplant diabetes mellitus, microRNA, kidney transplantation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To identify a panel of microRNAs at 3 months post-kidney transplant that are significantly associated with the development of PTDM within a defined follow-up period (e.g., 1 year, 2 years).	From enrollment to the end - 12 months	This measure quantifies the count of miRNAs that show statistically significant differential expression between patients who develop PTDM and those who do not within the follow-up period. The significance is determined based on adjusted p-values (\<0.05) and fold-change thresholds (e.g., \>2 or \<0.5). The data will be summarized as the total number of miRNAs passing these criteria for each patient group, providing a comparison of miRNA profiles at 3 months post-transplant.

Countries

Slovakia

Contacts

Primary ContactIvana Dedinska, prof, MD, PhD.

ivana.dedinska@uniba.sk+421 43 4203 920

Outcome results