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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients after primary kidney transplantation without type 1 or type 2 diabetes melltus |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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kidney transplant recipietns after pirmary kidney transplantation from post mortem or libing kidney donor.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivana Dedinska, prof, MD, PhD. | Contact | +421 43 4203 920 | ivana.dedinska@uniba.sk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transplant-nephorlogy department | Recruiting | Martin | 03601 | Slovakia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2025 | Jun 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| University hospital Martin | Recruiting | Martin | 03601 | Slovakia |
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