Predicting Development of Diabetes Mellitus in Patients Undergoing Allogeneic Stem Cell Transplant

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Malignant Neoplasm

In brief

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 (OGTT), euglycemic hyperinsulinemic clamps, and immune assays will be used to define the mechanisms associated with abnormal glucose homeostasis following stem cell transplantation. Information from this clinical trial could be used to develop standardized screening procedures or to develop optimal treatment strategies for patients developing post-transplant diabetes mellitus.

Key facts

Study ID

NCT02240381

Run by

Vanderbilt-Ingram Cancer Center

People needed

22

Starts

2014-11-20

Expected to finish

2019-01-08

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing MRD allogeneic HCT
• DONOR: Donors undergoing stem cell collection for match related allogeneic stem cell transplant

You may not qualify if…

• 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

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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