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

NCT ID: NCT02240381

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-20
• Study Completion Date: 2019-01-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

assessment of therapy complications

Intervention Type: PROCEDURE

During OGTT 75gm of glucose will be given followed by phlebotomy

assessment of therapy complications

Intervention Type: PROCEDURE

During clamp procedure tritiated glucose, D20, regular insulin will be given, followed by phlebotomy.

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

assessment of therapy complications

During OGTT 75gm of glucose will be given followed by phlebotomy

Intervention Type: PROCEDURE

assessment of therapy complications

During clamp procedure tritiated glucose, D20, regular insulin will be given, followed by phlebotomy.

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Brian Engelhardt, MD

Assistant Professor of Medicine, Hematologist/Oncologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Engelhardt

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

NCI-2014-01250

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC BMT 1426

Identifier Type: -

Identifier Source: org_study_id