Prospective Controlled Study of Posttransplant Diabetes

National Center for Research Resources (NCRR)

Status: Unknown

Conditions: Kidney Failure; Diabetes Mellitus

Treatments: Procedure: renal transplant

Study type: Observational

Funder types: NIH

Identifiers

NCT00006331

M01RR000042 (U.S. NIH Grant/Contract)

NCRR-M01RR00042-1699

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.