Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description


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.


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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03415139
Study type Observational
Source Vanderbilt-Ingram Cancer Center
Contact VICC Clinical Trials Information Program
Phone 800-811-8480
Status Recruiting
Start date January 31, 2019
Completion date April 2025

See also
  Status Clinical Trial Phase
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Active, not recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Completed NCT01340846 - A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors Phase 1
Recruiting NCT02565004 - Clinical and Laboratory Analysis of Familial Cancer
Active, not recruiting NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center N/A
Not yet recruiting NCT03662061 - Assessment of a Multidisciplinary Team Meeting (RCP) in Geriatric Oncology
Recruiting NCT03247309 - TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine) Phase 1
Completed NCT03272880 - Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers N/A
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Recruiting NCT03548077 - POWERPLAY: Promoting Men's Health at Work N/A
Completed NCT03503838 - A Pilot Study of Online Yoga for MPN Patients N/A
Completed NCT00984035 - Investigation of Cisplatin-Related Kidney Toxicity
Completed NCT01447186 - Adaptation of the American Cancer Society (ACS) Early Detection of Prostate Cancer Patient Decision Aid for Spanish Speaking Men N/A
Not yet recruiting NCT03257969 - Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors N/A