NCT02240381

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

Metabolic and CD4+ T Cell Dysregulation in Post-Transplant Diabetes Mellitus

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Diabetes Mellitus
• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	assessment of therapy complications	During OGTT 75gm of glucose will be given followed by phlebotomy
PROCEDURE	assessment of therapy complications	During clamp procedure tritiated glucose, D20, regular insulin will be given, followed by phlebotomy.
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-11-20
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2014-09-15
• Last updated: 2019-07-18

Locations

1 site across 1 country: United States