Prediction of NODAT After Renal Transplantation - Full Text View

Sponsored by:	Katholieke Universiteit Leuven
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00442988

Purpose

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	Phase
Renal Transplantation	Phase IV

MedlinePlus related topics: Diabetes Kidney Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
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).

Further study details as provided by Katholieke Universiteit Leuven:

Estimated Enrollment:	360
Study Start Date:	October 2000
Estimated Study Completion Date:	October 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442988

Locations

Belgium
Dpt of Nephrology and Renal Transplantation
Leuven, Belgium, B-3000

Sponsors and Collaborators

Katholieke Universiteit Leuven

Investigators

Principal Investigator:

Dirk R Kuypers, MD, PhD

Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium

More Information

No publications provided

Study ID Numbers:	NODAT
Study First Received:	March 2, 2007
Last Updated:	March 2, 2007
ClinicalTrials.gov Identifier:	NCT00442988 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:

NODAT
OGTT
FPG

Renal Transplanation
Risk Factors
Predictive value

Study placed in the following topic categories:

Diabetes Mellitus

ClinicalTrials.gov processed this record on May 07, 2009