Diabetes MellitusPOD-MIRNCT07055984
Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA
An observational study of Diabetes Mellitus and Kidney Transplant, run by University Hospital, Martin at 2 sites in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Kidney Transplant
- How many people
- 130 participants
- Where
- 2 sitesSlovakia
- Study dates
- 28 Apr 2025to 28 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: kidney transplant recipietns after pirmary kidney transplantation from post mortem or libing kidney donor.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia2 sites, 2 recruiting
- Recruiting
Transplant-nephorlogy department
Martin, 03601
Ivana Dedinska, prof, MD, PhD., +421434203184, ivana.dedinska@uniba.sk
Andrej Kollar, MD
- Recruiting
University hospital Martin
Martin, 03601
Ivana Dedinska, prof. MD, PhD., +421 43 4203 920, ivana.dedinska@uniba.sk
About this study
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.
- Conditions
- Diabetes Mellitus, Kidney Transplant
- Keywords
- post-transplant diabetes mellitus, microRNA, kidney transplantation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients after primary kidney transplantation without type 1 or type 2 diabetes melltus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start28 Apr 2025
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055984
- Sponsor's protocol ID
- University hospital Martin
- Acronym
- POD-MIR
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA
- ClinicalTrials.gov ID
- NCT07055984
- Acronym / sponsor ID
- POD-MIR / University hospital Martin
- Conditions
- Diabetes Mellitus, Kidney Transplant
- Keywords
- post-transplant diabetes mellitus, microRNA, kidney transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Apr 2029 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients after primary kidney transplantation without type 1 or type 2 diabetes melltus | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- kidney transplant recipietns after pirmary kidney transplantation from post mortem or libing kidney donor.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Kidney Transplant, run by University Hospital, Martin at 2 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivana Dedinska, prof, MD, PhD. (+421 43 4203 920, ivana.dedinska@uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.