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OpenTrials
Active, Not Recruiting

NCT Number: NCT03272854

TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention performed, the study is observational

Other

Primary outcomes

  1. All-Cause Mortality

    Time frame: 30 years

    All-Cause Mortality

  2. Graft Failure

    Time frame: 30 years

    Death-Censored Graft Failure

Secondary outcomes

  1. New Onset Diabetes After Transplantation

    Time frame: 30 years

    NODAT

  2. Cardiovascular Mortality

    Time frame: 30 years

    Cause-Specific Mortality

  3. Non-Cardiovascular Mortality

    Time frame: 30 years

    Cause-Specific Mortality

Other outcomes

  1. Venous Thrombosis

    Time frame: 30 years

    Venous Thrombosis

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: TxL-IRI

Important dates

Study start
2001
Primary completion
2003
Study completion
2031
First posted
Sep 6, 2017
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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