Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
55

Summary

Conditions
  • Cancer
  • Diabetes Mellitus
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

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). To determine if a compensatory increase in glucose st...

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). To determine if a compensatory increase in glucose stimulated insulin secretion (GSIS) by ?-cells precedes PTDM development in patients without diabetes undergoing MRD HCT. To determine if excess glucagon secretion and impaired ?-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.

Tracking Information

NCT #
NCT03415139
Collaborators
Not Provided
Investigators
Principal Investigator: Brian G. Engelhardt, M.D. Vanderbilt University Medical Center