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TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03272854
Acronym
TxL-IRI
Enrollment
606
Registered
2017-09-06
Start date
2001-08-31
Completion date
2031-08-31
Last updated
2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Death, Cardiac, Diabetes, Graft Failure

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).

Interventions

OTHERNo intervention performed, the study is observational

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-Cause Mortality30 yearsAll-Cause Mortality
Graft Failure30 yearsDeath-Censored Graft Failure

Secondary

MeasureTime frameDescription
New Onset Diabetes After Transplantation30 yearsNODAT
Cardiovascular Mortality30 yearsCause-Specific Mortality
Non-Cardiovascular Mortality30 yearsCause-Specific Mortality

Other

MeasureTime frameDescription
Venous Thrombosis30 yearsVenous Thrombosis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026