NCT Number: NCT03272854
TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study
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.
This study is active but is not currently recruiting participants.
Key information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
All-Cause Mortality
Time frame: 30 years
All-Cause Mortality
-
Graft Failure
Time frame: 30 years
Death-Censored Graft Failure
Secondary outcomes
-
New Onset Diabetes After Transplantation
Time frame: 30 years
NODAT
-
Cardiovascular Mortality
Time frame: 30 years
Cause-Specific Mortality
-
Non-Cardiovascular Mortality
Time frame: 30 years
Cause-Specific Mortality
Other outcomes
-
Venous Thrombosis
Time frame: 30 years
Venous Thrombosis
Sponsors and collaborators
Lead sponsor
University Medical Center Groningen
Other
Registry information
Acronym: TxL-IRI
Important dates
- Study start
- 2001
- Primary completion
- 2003
- Study completion
- 2031
- First posted
- Sep 6, 2017
- Registry last updated
- Sep 6, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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