Status:
UNKNOWN
Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Conditions:
Diabetes Mellitus
Cancer
Eligibility:
All Genders
18-90 years
Brief 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 (O...
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-...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients:
- Patients undergoing allogeneic hematopoietic stem cell transplantation (HCT).
- Exclusion Criteria for Patients:
- 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
- Umbilical cord blood transplants
- Patients on established, chronic corticosteroid therapy (\> 10 mg /day of prednisone or prednisone equivalent) prior to transplant; established, chronic corticosteroid therapy is defined as daily dosing of \> 10 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 (\> 10 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
- Additional exclusion criteria (Arms 1 and 2 Aim 1 only):
- Diagnosis of diabetes by standard oral glucose tolerance testing prior to transplant (2-hour plasma glucose value ≥ 200 mg/dL) in either Arm 1 or 2 will exclude further testing as per Aim 1. Immunological / metabolic testing as per Aim 2 will still be allowed
- DONORS Inclusion Criteria for Donors (Arm 1 and Arm 2) Donors undergoing stem cell collection for related allogeneic stem cell transplant
- Exclusion Criteria for Donors (Arms 1 and 2):
- Individuals not donating stem cells
- Pregnancy or breastfeeding
- Inability to give informed consent
- Any condition which, in the opinion of the investigator, might interfere with study objective
Exclusion
Key Trial Info
Start Date :
March 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03415139
Start Date
March 12 2019
End Date
April 1 2025
Last Update
March 28 2022
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232