TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

Study Overview
=================
Brief Summary
-----------------
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. This study is a biobank and cohort study which investigates this hypothesis.

Detailed Description
-----------------
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. To investigate this hypothesis we have detailedly phenotyped 606 renal transplant recipients who at the time of inclusion all were one year or more after transplantation, therewith providing a representation of stable outpatient renal trannsplant recipients late after renal transplantation. At the time of these baseline measurements, we also created a biobank with plasma, serum and aliquots of 24h urine collections. Beyond baseline, we have a regular update on adverse events, including all-cause mortality, cause-specific mortality, graft failure and development of new-onset diabetes after transplantation (NODAT).

Official Title
-----------------
TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

Conditions
-----------------
Death, Cardiac, Death, Graft Failure, Diabetes

Intervention / Treatment
-----------------
* Other: No intervention performed, the study is observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than one year after renal transplantation History of renal transplantation Exclusion Criteria: Signs of active infection Signs of active cardiac decompensation Active malignancy other than skin cancer Prognosis < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal Transplant Recipients<br>A cohort or renal transplant recipients, all more than 1 year after transplantation at inclusion | Other: No intervention performed, the study is observational<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | All-Cause Mortality | 30 years | 
| Graft Failure | Death-Censored Graft Failure | 30 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Onset Diabetes After Transplantation | NODAT | 30 years | 
| Cardiovascular Mortality | Cause-Specific Mortality | 30 years | 
| Non-Cardiovascular Mortality | Cause-Specific Mortality | 30 years |