Renal TransplantationNCT00442988
Prediction of NODAT After Renal Transplantation
An observational study of Renal Transplantation, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplantation
- How many people
- 360 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2000to Oct 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or secondary single kidney transplantation
- Age older than 18 years
Who cannot join
- Pre-existing DM or documented impaired glucose metabolism
- Combined organ transplantation
Trial locations and contacts
1 site in 1 country.
About this 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).
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.
Read the 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.
- Conditions
- Renal Transplantation
- Keywords
- NODAT, OGTT, FPG, Renal Transplanation, Risk Factors, Predictive value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startOct 2000
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Dirk R Kuypers, MD, PhD, Principal investigator, Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442988
- Sponsor's protocol ID
- NODAT
- Status last verified
- Mar 2007
- First submitted
- 2 Mar 2007
- Last updated
- 5 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00442988
- Acronym / sponsor ID
- NODAT
- Conditions
- Renal Transplantation
- Keywords
- NODAT, OGTT, FPG, Renal Transplanation, Risk Factors, Predictive value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2000
- Study completion
- Oct 2005
- First posted
- 5 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary or secondary single kidney transplantation
- Age older than 18 years
Key exclusion criteria (2 listed)
- Pre-existing DM or documented impaired glucose metabolism
- Combined organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk R Kuypers, MD, PhD principal investigator
Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2007.