Risk Factors for Diabetes After Stem Cell Transplantation
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation|
|Study Start Date:||November 2005|
|Study Completion Date:||March 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539851
|Principal Investigator:||Shubhada Jagasia, MD||Vanderbilt University|