Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA
POD-MIR
1 other identifier
observational
130
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2025
CompletedFirst Submitted
Initial submission to the registry
June 9, 2025
CompletedFirst Posted
Study publicly available on registry
July 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2029
July 9, 2025
June 1, 2025
3 years
June 9, 2025
June 27, 2025
Conditions
Keywords
Outcome Measures
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).
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.
From enrollment to the end - 12 months
Study Arms (1)
patients after primary kidney transplantation without type 1 or type 2 diabetes melltus
Eligibility Criteria
kidney transplant recipietns after pirmary kidney transplantation from post mortem or libing kidney donor.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Transplant-nephorlogy department
Martin, 03601, Slovakia
University hospital Martin
Martin, 03601, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study coordinator
Study Record Dates
First Submitted
June 9, 2025
First Posted
July 9, 2025
Study Start
April 28, 2025
Primary Completion (Estimated)
April 28, 2028
Study Completion (Estimated)
April 28, 2029
Last Updated
July 9, 2025
Record last verified: 2025-06