Predicting Development of Diabetes Mellitus in Patients Undergoing Allogeneic Stem Cell Transplant
Purpose
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.
Conditions
- Diabetes Mellitus
- Malignant Neoplasm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Diagnostic (OGTT, euglycemic hyperinsulinemic clamp) |
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. |
|
More Details
- Status
- Terminated
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
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 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.