Risk Factors for Diabetes After Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00539851
First received: October 4, 2007
Last updated: March 18, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539851

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

No publications provided

Responsible Party: Shubhada Jagasia, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00539851     History of Changes
Other Study ID Numbers: #040639
Study First Received: October 4, 2007
Last Updated: March 18, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014