NCT00006331

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

October 4, 2000

Last Update Submit

June 27, 2005

Conditions

Diabetes MellitusKidney Failure

Keywords

Kidney transplantationImmunology

Interventions

renal transplantPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3914 Taubman Center

Ann Arbor, Michigan, 48109-0364, United States

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Akinlolu O. Ojo, M.D., Ph.D.

CONTACT

1-734-763-9041aojo@umich.edu

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

October 4, 2000

First Posted

October 5, 2000

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)