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NCT00442988 Clinical Trial

Prediction of NODAT After Renal Transplantation

Renal Transplantation Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00442988
Other study ID # NODAT
Secondary ID
Status Completed
Phase Phase 4
First received March 2, 2007
Last updated March 2, 2007
Start date October 2000
Est. completion date October 2005

Study information
Verified date March 2007
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 360
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Dpt of Nephrology and Renal Transplantation Leuven

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

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