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NCT Number: NCT07055984

Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Kidney Transplant Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Transplant-nephorlogy department, Martin, Slovakia

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Registry information

Acronym: POD-MIR

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

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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