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

Vanderbilt University Medical Center

Status

Terminated

Conditions

Malignant Neoplasm

Diabetes Mellitus

Treatments

Other: laboratory biomarker analysis

Procedure: assessment of therapy complications

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02240381

VICC BMT 1426

P30CA068485 (U.S. NIH Grant/Contract)

NCI-2014-01250 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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