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Prediction of NODAT After Renal Transplantation

Sponsor
KU Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT00442988
Collaborator
(none)
360
Enrollment
1
Location
60
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A statistical analysis of the predictive value of OGTT and FPG testing executed as part of standard clinical practice after renal transplantation for the diagosis of new-onset diabetes mellitus after transplantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patients transplanted in our department receive a formal oral glucose tolerance test (and thus also fasting plasma glucose concentration) in the first week after renal transplantation. This testing for DM or Impaired Glucose Tolerance (IGT) is part of our standard clinical protocol and data are collected prospectively in all these patients in an electronic patient medical file. The development of diabetes mellitus in all transplant patients is documented, including DM therapy.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Official Title:
    Early Prediction of New Onset Diabetes Mellitus After Transplantation (NODAT) in Renal Transplantation: Use of Oral Glucose Tolerance Test (OGTT) and Fasting Plasma Glucose (FPG).
    Study Start Date :
    Oct 1, 2000
    Study Completion Date :
    Oct 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Primary or secondary single kidney transplantation

      • Age older than 18 years

      Exclusion Criteria:

      • Pre-existing DM or documented impaired glucose metabolism

      • Combined organ transplantation

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Dpt of Nephrology and Renal Transplantation Leuven Belgium B-3000

      Sponsors and Collaborators

      • KU Leuven

      Investigators

      • Principal Investigator: Dirk R Kuypers, MD, PhD, Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00442988
      Other Study ID Numbers:
      • NODAT
      First Posted:
      Mar 5, 2007
      Last Update Posted:
      Mar 5, 2007
      Last Verified:
      Mar 1, 2007
      Keywords provided by , ,
      NODAT
      OGTT
      FPG
      Renal Transplanation
      Risk Factors
      Predictive value

      Study Results

      No Results Posted as of Mar 5, 2007