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

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 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.

OUTLINE:

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
transplant

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
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