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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02811835
Collaborator
(none)
1,007
Enrollment
240
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1007 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Actual Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    May 1, 2011
    Anticipated Study Completion Date :
    Nov 1, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Renal Transplant Recipients

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

    Healthy subjects being evaluated as potential living kidney donors

    Outcome Measures

    Primary Outcome Measures

    1. Graft failure [20 years]

      Return to dialysis or re-transplantation

    2. All-cause mortality [20 years]

      Death

    Secondary Outcome Measures

    1. Cardiovascular mortality [20 years]

      Cause specific mortality

    2. Cancer mortality [20 years]

      Cause specific mortality

    3. Infectious disease mortality [20 years]

      Cause specific mortality

    Other Outcome Measures

    1. Change in renal function [20 years]

      Change in renal function over time

    2. New Onset Diabetes After Transplantation [20 years]

      New Onset Diabetes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

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

    Exclusion Criteria: Acute illnesses, fever, current hospitalisation

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephan J.L. Bakker, Prof. dr., University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT02811835
    Other Study ID Numbers:
    • METc2008/186
    First Posted:
    Jun 23, 2016
    Last Update Posted:
    Aug 22, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes

    Study Results

    No Results Posted as of Aug 22, 2017