Status:
TERMINATED
Predicting Development of Diabetes Mellitus in Patients Undergoing Allogeneic Stem Cell Transplant
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Diabetes Mellitus
Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial studies the physiology and immunology of new-onset post-transplant diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose tolerance testing (OG...
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether pre-transplant insulin resistance predicts for the development of new onset post-transplant diabetes mellitus (PTDM) in individuals without diabetes underg...
Eligibility Criteria
Inclusion
- Patients undergoing MRD allogeneic HCT
- DONOR: Donors undergoing stem cell collection for match related allogeneic stem cell transplant
Exclusion
- Patients who have not received an allogeneic HCT
- Recent or current history of diabetes mellitus, defined as:1) diabetes therapy within 6 months of enrollment, or 2) fasting blood glucose at "pre-admit" (screening) visit \>= 126 mg/dL
- Pregnancy or breastfeeding
- Unrelated donor, umbilical cord blood, mismatched, or haploidentical transplants
- Patients receiving T cell depletion or thymoglobulin as part of their transplant
- Patients on established, chronic corticosteroid therapy (\> 5 mg /day of prednisone or prednisone equivalent) prior to transplant; established, chronic corticosteroid therapy is defined as daily dosing of \> 5 mg/day of prednisone or prednisone equivalent for at least 2 weeks prior to the start of conditioning/chemotherapy or plans to continue pre-transplant corticosteroids (\> 5 mg/day of prednisone or prednisone equivalent) indefinitely after transplantation
- Inability to give informed consent
- Any condition which, in the opinion of the investigator, might interfere with study objective
- Any reason which, in the opinion of the investigator, adds additional risk to the patient
- DONOR: Individuals not donating stem cells
- DONOR: Pregnancy or breastfeeding
- DONOR: Inability to give informed consent
- DONOR: Any condition which, in the opinion of the investigator, might interfere with study objective
Key Trial Info
Start Date :
November 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02240381
Start Date
November 20 2014
End Date
January 8 2019
Last Update
July 18 2019
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232