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

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ClinicalTrials.gov Identifier: NCT03272854
Recruitment Status : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Stephan J.L. Bakker, University Medical Center Groningen

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 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.

Condition or disease Intervention/treatment
Death Graft Failure Death, Cardiac Diabetes Other: No intervention performed, the study is observational

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 606 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study
Actual Study Start Date : August 2001
Actual Primary Completion Date : July 2003
Estimated Study Completion Date : August 2031

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



Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 30 years ]
    All-Cause Mortality

  2. Graft Failure [ Time Frame: 30 years ]
    Death-Censored Graft Failure


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Venous Thrombosis [ Time Frame: 30 years ]
    Venous Thrombosis


Biospecimen Retention:   Samples Without DNA
EDTA plasma, serum, aliquots of 24h urine collections all stored at -80 degrees Centigrade.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable outpatient renal transplant recipients more than 1 year after transplantation,
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272854


Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Stephan JL Bakker, MD, PhD University Medical Center Groningen
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stephan J.L. Bakker, Internist-Neprologist, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03272854    
Other Study ID Numbers: METc2001/039
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Inflammation
Death
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases