Prospective Controlled Study of Posttransplant Diabetes

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Akinlolu O. Ojo, M.D., Ph.D.
  • Phone Number: 1-734-763-9041
  • Email: aojo@umich.edu

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0364
        • Recruiting
        • 3914 Taubman Center
        • Contact:
          • Akinlolu O. Ojo, M.D.
          • Phone Number: 734-763-9041
          • Email: aojo@umich.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

October 4, 2000

First Posted (Estimate)

October 5, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 27, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00042-1699
  • M01RR000042 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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