Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Martin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
kidney transplant recipietns after pirmary kidney transplantation from post mortem or libing kidney donor.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 1 trial groupGroup A: patients after primary kidney transplantation without type 1 or type 2 diabetes melltus
Trial outcomes
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.
Time frame
From enrollment to the end - 12 monthsSponsors and contacts
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Source ClinicalTrials.gov