TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)

University Medical Center Groningen (UMCG)

Status: Active, not recruiting

Conditions: Renal Transplant Donor of Left Kidney; Transplantation Infection

Study type: Observational

Funder types: Other

Identifiers

NCT02811835

METc2008/186

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 due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results. 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 due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results.

To investigate one part of this overarching hypothesis, the investigators wrote a project on around the specific topic of the relation between dietary acid load, ammoniagenesis and its potential influence on blood pressure. The investigators used this project to build a biobank and cohort in which they can test additional hypotheses on the relation between diet, contaminants and development of graft failure and the occurrence of mortality.

The investigators also included 300 healthy controls to compare diet, contaminant exposure and biomarkers with the renal transplant recipients.

Enrollment: 1,007 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: More than one year after transplantation, prognosis > 1 year, stable outpatients situation -

Exclusion Criteria: Acute illnesses, fever, current hospitalisation

Trial design

1,007 participants in 2 patient groups

Renal Transplant Recipients

Description:

Renal Transplant Recipients that were more than 1 year post-transplantation

Healthy Controls

Description:

Healthy subjects being evaluated as potential living kidney donors