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Risk Factors for Diabetes After Stem Cell Transplantation

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. Identifier: NCT00539851
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : March 19, 2010
Information provided by:
Vanderbilt University

Brief Summary:
This study is proposed to investigate the incidence of Post Transplant Diabetes Mellitus (PTDM) as well as associated risk factors for the development of PTDM in patients undergoing allogenic stem cell transplantation.

Condition or disease
Diabetes Mellitus

Detailed Description:

Allogenic stem cell transplantation from related or unrelated donors has been used successfully to cure patients with a variety of hematological malignancies. Graft-versus-host disease (GVHD) is an alloreactive immune phenomenon, where the activated donor T cells recognizes the recipient as being foreign and effects a cytotoxic response. GVHD occurring in the first 100 days after transplantation is termed acute GVHD and is characterized by hepatitis, dermatitis, and enteritis.

High dose corticosteroids remain one of the cornerstone therapies to treat acute GVHD. However, an association between corticosteroid therapy and the development of diabetes mellitus after solid organ transplantation has become widely recognized. Similarly, post transplant diabetes mellitus (PTDM) has been increasingly noted in the allogenic stem cell transplant population, however, to date, no systematic study has been completed to identify the incidence of PTDM and associated risk factors. We propose to investigate the incidence of PTDM as well as associated risk factors for the development of PTDM in patients undergoing allogenic stem cell transplantation.

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation
Study Start Date : November 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : March 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be enrolled through the Endocrinology, Hematology and Stem Cell Transplantation Clinics at Vanderbilt University Medical Center.

Inclusion Criteria:

  • 18 - 65 years or age
  • Fulfills institutional criteria for and is scheduled to undergo an allogenic stem cell transplantation at VUMC

Exclusion Criteria:

  • Younger than 18 years or older than 65 years
  • Pre-existing diabetes mellitus
  • Positive pregnancy test
  • Unable to complete the conditioning regimen prior to stem cell transplantation
  • Unable to give informed consent

Information from the National Library of Medicine

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 identifier (NCT number): NCT00539851

Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: Shubhada Jagasia, MD Vanderbilt University Medical Center

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Responsible Party: Shubhada Jagasia, MD, Vanderbilt University Medical Center Identifier: NCT00539851     History of Changes
Other Study ID Numbers: #040639
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: March 2010
Keywords provided by Vanderbilt University:
Allogenic Stem Cell Transplantation
Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases