TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study (TxL-IRI)

University Medical Center Groningen (UMCG)

Status: Active, not recruiting

Conditions: Death, Cardiac; Graft Failure; Death; Diabetes

Treatments: Other: No intervention performed, the study is observational

Study type: Observational

Funder types: Other

Identifiers

NCT03272854

METc2001/039

Details and patient eligibility

About

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.

Full 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).

Enrollment: 606 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

606 participants in 1 patient group

Renal Transplant Recipients

Description:

A cohort or renal transplant recipients, all more than 1 year after transplantation at inclusion

Treatment:

Other: No intervention performed, the study is observational