Risk Factors for Diabetes After Stem Cell Transplantation

Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00539851

Enrollment

Registered

2007-10-05

Start date

2005-11-30

Completion date

2010-03-31

Last updated

2010-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Allogenic Stem Cell Transplantation, Diabetes Mellitus

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Outcome results