Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA
Conditions: Diabetes Mellitus, Kidney Transplant
Sponsor: University Hospital, Martin

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
 
 
 
 
STUDY TITLE 
Predicting Outcomes in Diabetes via microRNA 
PRODIGY 
 
 
 
NCT number:  
 
 
 
 
 
 
 
 
 
 
 
In Martin, Slovakia     27th May 2025 

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
 
1. Research Question and Objectives: 
• Primary Research Question: Can specific microRNA profiles at 3 months 
post-kidney transplant predict the development of PTDM? 
• Secondary Research Question: How do traditional risk factors (age, 
immunosuppression, obesity, CMV infection) and their interaction with specific  
• 
Primary Objective: 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). 
• 
Secondary Objectives: 
o 
To assess the association between traditional risk factors (age, 
immunosuppression, obesity, CMV infection) and the development of PTDM. 
o 
To investigate the interaction between specific microRNAs and traditional risk 
factors in predicting PTDM. 
o 
To explore the correlation between specific microRNA expression  
2. Study Design: 
• 
Type: Prospective Observational Cohort single center Study 
3. Study Population: 
• 
Inclusion Criteria: 
o 
Adult patients undergoing kidney transplantation. 
o 
Absence of pre-existing type 1 or type 2 diabetes mellitus. 
o 
Willingness to provide informed consent and comply with study procedures. 
• 
Exclusion Criteria: 
o 
Pre-existing type 1 or type 2 diabetes mellitus. 
o 
Previous organ transplantation. 
o 
Severe comorbidities that could confound the assessment of PTDM (e.g., 
pancreatic disease). 
o 
Inability to provide informed consent. 
• 
Recruitment: 
o 
Consecutive enrollment of eligible patients undergoing kidney transplantation 
at your center(s). 
• 
Total Sample Size: 64 patients (PTDM group) + 64 patients (non-PTDM group) = 
128 patients 
4. Data Collection and Procedures – see table 1: 
• 
Baseline Data: 
o 
Demographics (age, sex, ethnicity) 
o 
Medical history (including pre-transplant comorbidities) 
o 
Transplant-related data (donor source, cold ischemia time, etc.) 
o 
Immunosuppression regimen (specific drugs and dosages) 
o 
Weight, height (for BMI calculation) 
o 
CMV status (pre- and post-transplant) 
• 
3-Month Visit: 

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
o 
Blood sample for microRNA profiling (collect and store appropriately for later 
analysis) 
o 
Oral Glucose Tolerance Test (oGTT) - Follow standardized protocols for 
administration and interpretation. 
• 
12-month Follow-up: 
o 
Regular monitoring for the development of PTDM (based on established 
diagnostic criteria, e.g., ADA criteria). 
o 
Collection of data on immunosuppression changes, CMV infections, and other 
relevant clinical events. 
o 
Define a specific follow-up period (e.g., 1 year, 2 years) to determine the 
incidence of PTDM. 
5. Outcome Measures: 
• 
Primary Outcome: Development of PTDM within the defined follow-up period 
(diagnosed according to ADA criteria or other established criteria). 
• 
Secondary Outcomes: 
o 
Specific microRNA expression levels at 3 months. 
o 
Correlation between microRNA expression and oGTT results. 
o 
Association between traditional risk factors and PTDM. 
o 
Interaction between microRNAs and traditional risk factors in predicting 
PTDM. 
6. Data Analysis: 
• 
Statistical Methods: 
o 
Repeated Measures Analysis: statistical methods that can handle repeated 
measures data, such as repeated measures ANOVA or mixed-effects models. 
o 
Correlation Analysis: correlation between microRNA expression levels and the 
results of the standard oGTT  
 
 
 
 
 
 
 
 
 

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
 
 
 
base line 
M3 
M12 
Age at KT (years) 
X 
 
 
Donor type (SCD/ECD/living) 
X 
 
 
Weight (kg) 
X 
X 
X 
Waist circumference (cm) 
X 
X 
X 
BMI (kg/m2) 
X 
X 
X 
ADPKD (yes/no) 
X 
 
 
Duration of dialysis (months) 
X 
 
 
Family history of DM* 
X 
 
 
Induction (basiliximab/ATG) 
X 
 
 
TAC level (ng/ml) 
 
X 
X 
Corticosteroid dose (mg/day) 
 
X 
X 
History of acute rejection 
 
X 
X 
- If yes, treatment (CS/IA/PF/IVIg/Rtx/dara) 
 
X 
X 
OGTT – standard** 
X 
X 
X 
HbA1c (%) 
 
X 
X 
C-peptide (μg/l) fasting + 2 hours after meal 
 
X 
X 
Immunoreactive insulin (mU/l) + 2 hours after meal 
 
X 
X 
HOMA-IR 
 
X 
X 
eGFR (ml/min) 
 
X 
X 
Creatinine (mol/l) 
 
X 
X 
cholesterol (mmol/l) 
 
X 
X 
LDL (mmol/l) 
 
X 
X 

UNIVERZITNÁ  NEMOCNICA  MARTIN 
 
KOLLÁROVA  2,  036 59 MARTIN  
Transplantačno-nefrologické oddelenie 
Transplant-nephrology department 
  
tc@unm.sk 
+ 421 43 4203 184 
 
HDL (mmol/l) 
 
X 
X 
Triglycerides (mmol/l) 
 
X 
X 
Hb (g/l) 
 
X 
X 
CMV PCR (cop/ml) 
 
X 
X 
microRNA 
 
X 
 
M – month, KT – kidney transplantation, SCD – donor with standard criteria, ECD – donor with expanded criteria, BMI – body mass index, 
ADPKD – autosomal dominant polycystic kidney disease, DM – diabetes mellitus, ATG – antithymocyte globulin, TAC – tacrolimus, KS – 
corticosteroids, IA – immunoadsorption, PF – plasma exchange, IvIg – intravenous immunoglobulins, RTx – rituximab 
dara – daratumumab, oGTT – oral glucose tolerance test, HbA1c – glycated hemoglobin, eGFR – estimated glomerular filtration rate (according 
to CKD-EPI), LDL – low-density lipoproteins, HDL – high-density lipoproteins, Hb – hemoglobin, CMV – cytomegalovirus, PCR – 
polymerase chain reaction 
*Parents, grandparents, siblings, children 
** OGTT will be performed in patients without antidiabetic treatment (insulin and/or oral antidiabetics) 
Table 1