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Prospective Controlled Study of Posttransplant Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006331
First Posted: October 5, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Research Resources (NCRR)
  Purpose

Research participants will be asked to undergo complete medical history, physical examination and blood tests. The purpose of these tests is to determine whether persons are predisposed to develop diabetes mellitus after kidney transplantation and also to make an early diagnosis if a patient develops diabetes mellitus. Medical information collected as part of the standard transplant evaluation and posttransplant medical care may be incorporated into this study. It is important to realize that research subjects will not be given an experimental drug as part of this study.

After kidney transplantation, research subjects will be followed in the posttransplant clinic visits. The study will last up to 6 months. During this time the subjects may be asked to participate in clinical assessment visits (medical history and physical examination), and also during the third or fourth month after transplant will be asked to do a repeat glucose tolerance test.


Condition Intervention
Diabetes Mellitus Kidney Failure Procedure: renal transplant

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fasting Plasma Glucose (FPG) <126mg/dl.
  • No history of diabetes mellitus or treatment with oral antidiabetic agent or insulin.
  • ESRD or chronic renal failure with CrCl <= 20cc/min per 1.73m2.
  • Waiting list registration for cadaveric or set date for living donor renal transplantation.
  • Willingness and ability to understand and give informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006331


Contacts
Contact: Akinlolu O. Ojo, M.D., Ph.D. 1-734-763-9041 aojo@umich.edu

Locations
United States, Michigan
3914 Taubman Center Recruiting
Ann Arbor, Michigan, United States, 48109-0364
Contact: Akinlolu O. Ojo, M.D.    734-763-9041    aojo@umich.edu   
Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

ClinicalTrials.gov Identifier: NCT00006331     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1699
M01RR000042 ( U.S. NIH Grant/Contract )
First Submitted: October 4, 2000
First Posted: October 5, 2000
Last Update Posted: December 9, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
Kidney transplantation
Immunology

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases