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

Renal Sensing of the Acidifying Effect of Sulphur-containing Amino Acids: Consequences for the Relation Between Protein Intake and Blood Pressure in Renal Transplant Recipients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02811835
Acronym
TxL-FN
Enrollment
1007
Registered
2016-06-23
Start date
2008-11-30
Completion date
2028-11-30
Last updated
2017-08-22

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

Conditions

Renal Transplant Donor of Left Kidney, Transplantation Infection

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 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.

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 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.

Interventions

None listed

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
Yes

Inclusion criteria

More than one year after transplantation, prognosis \> 1 year, stable outpatients situation -

Exclusion criteria

Acute illnesses, fever, current hospitalisation \-

Design outcomes

Primary

MeasureTime frameDescription
Graft failure20 yearsReturn to dialysis or re-transplantation
All-cause mortality20 yearsDeath

Secondary

MeasureTime frameDescription
Infectious disease mortality20 yearsCause specific mortality
Cancer mortality20 yearsCause specific mortality
Cardiovascular mortality20 yearsCause specific mortality

Other

MeasureTime frameDescription
Change in renal function20 yearsChange in renal function over time
New Onset Diabetes After Transplantation20 yearsNew Onset Diabetes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026