Diabetes MellitusNCT00539851
Risk Factors for Diabetes After Stem Cell Transplantation
An observational study of Diabetes Mellitus, run by Vanderbilt University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be enrolled through the Endocrinology, Hematology and Stem Cell Transplantation Clinics at Vanderbilt University Medical Center.
Who may be able to join
- 18 - 65 years or age
- Fulfills institutional criteria for and is scheduled to undergo an allogenic stem cell transplantation at VUMC
Who cannot join
- 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
About this study
Official title: Risk Factors for Developing Diabetes Mellitus After Allogenic 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.
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.
- Conditions
- Diabetes Mellitus
- Keywords
- Allogenic Stem Cell Transplantation, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startNov 2005
- Primary completionAug 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Shubhada Jagasia, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539851
- Sponsor's protocol ID
- #040639
- Status last verified
- Mar 2010
- First submitted
- 4 Oct 2007
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Developing Diabetes Mellitus After Allogenic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00539851
- Acronym / sponsor ID
- #040639
- Conditions
- Diabetes Mellitus
- Keywords
- Allogenic Stem Cell Transplantation, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Nov 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be enrolled through the Endocrinology, Hematology and Stem Cell Transplantation Clinics at Vanderbilt University Medical Center.
Key inclusion criteria (2 listed)
- 18 - 65 years or age
- Fulfills institutional criteria for and is scheduled to undergo an allogenic stem cell transplantation at VUMC
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubhada Jagasia, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2010.