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CompletedNCT00539851Updated Mar 19, 2010

Risk Factors for Diabetes After Stem Cell Transplantation

An observational study in Diabetes Mellitus, sponsored by Vanderbilt University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-03-19.

Sponsored by Vanderbilt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
87
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Allogenic Stem Cell Transplantation
  • Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 87 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
87 participants (actual)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00539851
Lead sponsor
Vanderbilt University
Collaborators
Sanofi
First posted
Oct 5, 2007
Start date
Nov 2005
Primary completion
Aug 2009
Completion
Mar 2010
Last update
Mar 19, 2010

Study contacts

Shubhada Jagasia, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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