Prospective Controlled Study of Posttransplant Diabetes

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. Identifier: NCT00006331
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : October 5, 2000
Last Update Posted : June 28, 2005
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:

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 or disease Intervention/treatment
Diabetes Mellitus Kidney Failure Procedure: renal transplant

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

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U.S. FDA Resources

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00006331

Contact: Akinlolu O. Ojo, M.D., Ph.D. 1-734-763-9041

United States, Michigan
3914 Taubman Center Recruiting
Ann Arbor, Michigan, United States, 48109-0364
Contact: Akinlolu O. Ojo, M.D.    734-763-9041   
Sponsors and Collaborators
National Center for Research Resources (NCRR) Identifier: NCT00006331     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1699
M01RR000042 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2000    Key Record Dates
Last Update Posted: June 28, 2005
Last Verified: December 2003

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

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