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Risk Factors for Diabetes After Stem Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539851
First Posted: October 5, 2007
Last Update Posted: March 19, 2010
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.
Collaborator:
Sanofi
Information provided by:
Vanderbilt University
  Purpose
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
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation

Further study details as provided by Vanderbilt University:

Enrollment: 87
Study Start Date: November 2005
Study Completion Date: March 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00539851


Sponsors and Collaborators
Vanderbilt University
Sanofi
Investigators
Principal Investigator: Shubhada Jagasia, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Shubhada Jagasia, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00539851     History of Changes
Other Study ID Numbers: #040639
First Submitted: October 4, 2007
First Posted: October 5, 2007
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:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases