TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

Active, not recruiting

• Conditions: Death, Cardiac; Graft Failure; Death; Diabetes
• Interventions: Other: No intervention performed, the study is observational

• Registration Number: NCT03272854
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2003-07
• Status Verified: 2017-09
• Study First Submitted: 2017-09-02
• Study First Submitted QC: 2017-09-02
• Last Update Submitted: 2017-09-02
• Study First Posted: 2017-09-06
• Last Update Posted: 2017-09-06
• Study Completion: 2031-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 606

Inclusion Criteria

• More than one year after renal transplantation
• History of renal transplantation

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Exclusion Criteria

• Signs of active infection
• Signs of active cardiac decompensation
• Active malignancy other than skin cancer
• Prognosis < 1 year

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	30 years	All-Cause Mortality
Graft Failure	30 years	Death-Censored Graft Failure

Secondary Outcome Measures

Name	Time	Method
New Onset Diabetes After Transplantation	30 years	NODAT
Cardiovascular Mortality	30 years	Cause-Specific Mortality
Non-Cardiovascular Mortality	30 years	Cause-Specific Mortality