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

September 2, 2017 updated by: Stephan J.L. Bakker, University Medical Center Groningen
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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).

Study Type

Observational

Enrollment (Actual)

606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stable outpatient renal transplant recipients more than 1 year after transplantation,

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal Transplant Recipients
A cohort or renal transplant recipients, all more than 1 year after transplantation at inclusion
Other: No intervention performed, the study is observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 30 years
All-Cause Mortality
30 years
Graft Failure
Time Frame: 30 years
Death-Censored Graft Failure
30 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Onset Diabetes After Transplantation
Time Frame: 30 years
NODAT
30 years
Cardiovascular Mortality
Time Frame: 30 years
Cause-Specific Mortality
30 years
Non-Cardiovascular Mortality
Time Frame: 30 years
Cause-Specific Mortality
30 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous Thrombosis
Time Frame: 30 years
Venous Thrombosis
30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Stephan JL Bakker, MD, PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2001

Primary Completion (Actual)

July 1, 2003

Study Completion (Anticipated)

August 1, 2031

Study Registration Dates

First Submitted

September 2, 2017

First Submitted That Met QC Criteria

September 2, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METc2001/039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data can be shared with other researchers. The researchers will then receive an anonymized dataset. The PI of the study will be co-author on papers that come out of the analyses.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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