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Risk Factors for Diabetes After Stem Cell Transplantation

Vanderbilt University logo

Vanderbilt University

Status

Completed

Conditions

Diabetes Mellitus

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00539851
#040639

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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