Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant
NCT ID: NCT03415139
Last Updated: 2022-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-03-12
2025-04-30
Brief Summary
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Detailed Description
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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.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm 1 for MRD HCT Recipients
Patients undergo an Oral Glucose Tolerance Test (OGTT) and 1 hyperglycemic clamp will be performed on separate days prior to transplant and then each procedure will be repeated once between day+80 to day+100 (+/- 10 days) after transplant.
Oral Glucose Tolerance Test (OGTT)
A standard OGTT will be performed. During OGTT 75gm of glucose will be given followed by phlebotomy.
Hyperglycemic clamp procedure
During the hyperglycemic clamp procedure, D20 will given, followed by phlebotomy.
Arm 2 for MRD HCT Recipients
Patients undergo 2 Oral Glucose Tolerance Test (OGTTs) (with and without GLP-1 analogue) will be performed on separate days prior to transplant and then each procedure will be repeated once between day+80 to day+100 (+/- 10 days) after transplant.
2 OGTTs with and without GLP-1 analogue
A standard OGTT will be performed and a second OGTT procedure will be repeated on a different day with GLP-1 analogue.
Interventions
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Oral Glucose Tolerance Test (OGTT)
A standard OGTT will be performed. During OGTT 75gm of glucose will be given followed by phlebotomy.
2 OGTTs with and without GLP-1 analogue
A standard OGTT will be performed and a second OGTT procedure will be repeated on a different day with GLP-1 analogue.
Hyperglycemic clamp procedure
During the hyperglycemic clamp procedure, D20 will given, followed by phlebotomy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
-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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Brian Engelhardt, MD
Associate Professor of Medicine
Principal Investigators
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Brian G. Engelhardt, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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VICC Clinical Trials Information Program
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VICC CTT 1836
Identifier Type: -
Identifier Source: org_study_id
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