Prospective Controlled Study of Posttransplant Diabetes
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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. |
| ClinicalTrials.gov Identifier: NCT00006331 |
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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
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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 |
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 |
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.
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
| Contact: Akinlolu O. Ojo, M.D., Ph.D. | 1-734-763-9041 | aojo@umich.edu |
| 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 | |
| ClinicalTrials.gov 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):
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Kidney transplantation Immunology |
Additional relevant MeSH terms:
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Diabetes Mellitus Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Kidney Diseases Urologic Diseases |