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

Therapuetic Areas:Endocrinology
Age Range:18 - Any
Start Date:March 2015
End Date:December 2020
Contact:VICC Clinical Trials Information Program

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Metabolic and CD4+ T Cell Dysregulation in Post-Transplant Diabetes Mellitus

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.


I. To determine whether pre-transplant insulin resistance predicts for the development of new
onset post-transplant diabetes mellitus (PTDM) in individuals without diabetes undergoing
matched related donor (MRD) hematopoietic stem cell transplant (HCT).

II. To define the role of circulating tissue-specific Th1 cells in the development of PTDM.

III. To characterize the phenotype and function of circulating tissue-specific regulatory T
cells (Tregs) in HCT recipients with or without PTDM.


Patients undergo OGTT and a standard 2-step euglycemic hyperinsulinemic clamp procedure prior
to HCT. Patients then undergo repeat OGTT and a 2-step euglycemic hyperinsulinemic clamp
procedure once after HCT between days 90-100.

Inclusion Criteria:

- Patients undergoing MRD allogeneic HCT

- DONOR: Donors undergoing stem cell collection for match related allogeneic stem cell

Exclusion Criteria:

- 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

- Any reason which, in the opinion of the investigator, adds additional risk to the

- 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
We found this trial at
2220 Pierce Ave
Nashville, Tennessee 37232
Principal Investigator: Brian G. Engelhardt
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
Nashville, TN
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