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NCT00006331 Clinical Trial

Prospective Controlled Study of Posttransplant Diabetes

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00006331
Other study ID # NCRR-M01RR00042-1699
Secondary ID M01RR000042
Status Recruiting
Phase N/A
First received October 4, 2000
Last updated June 27, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact Akinlolu O. Ojo, M.D., Ph.D.
Phone 1-734-763-9041
Email aojo@umich.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• renal transplant

Locations
Country Name City State
United States 3914 Taubman Center Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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