NCT03415139

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Cancer

Interventions

Type	Name	Description
DRUG	Oral Glucose Tolerance Test (OGTT)	A standard OGTT will be performed. During OGTT 75gm of glucose will be given followed by phlebotomy.
DRUG	2 OGTTs with and without GLP-1 analogue	A standard OGTT will be performed and a second OGTT procedure will be repeated on a different day with GLP-1 analogue.
DRUG	Hyperglycemic clamp procedure	During the hyperglycemic clamp procedure, D20 will given, followed by phlebotomy.

Timeline

• Start date: 2019-03-12
• Primary completion: 2023-04-01
• Completion: 2025-04-01
• First posted: 2018-01-30
• Last updated: 2022-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study