Spots Global Cancer Trial Database for Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant

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Trial Identification

Brief Title: Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant

Official Title: Islet Cell and ST2 Axis Dysregulation in Post-Transplant Diabetes Mellitus

Study ID: NCT03415139

Conditions

Diabetes Mellitus

Cancer

Interventions

Oral Glucose Tolerance Test (OGTT)

2 OGTTs with and without GLP-1 analogue

Hyperglycemic clamp procedure

Study Description

Brief Summary: This clinical research studies the physiology and immunology of new-onset post-transplant diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose tolerance tests (OGTT), hyperglycemic 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine if changes in islet cell physiology are detectable before or after matched related donor (MRD) hematopoietic stem cell transplant (HCT) in patients developing new-onset post-transplant diabetes mellitus (PTDM). 1. To determine if a compensatory increase in glucose stimulated insulin secretion (GSIS) by β-cells precedes PTDM development in patients without diabetes undergoing MRD HCT. 2. To determine if excess glucagon secretion and impaired α-cell response to glucose or GLP-1 contributes to the hyperglycemia of PTDM. II. To determine if the IL-33/ST2 axis promotes immune/islet cell dysregulation during PTDM. OUTLINE: Patients undergo 2 OGTTs and a standard hyperglycemic clamp procedure prior to HCT. Patients then undergo repeat OGTTs and a hyperglycemic clamp procedure once after HCT between days 80-100.