Clinical trial · Interventional
Predicting Development of Diabetes Mellitus in Patients Undergoing Allogeneic Stem Cell Transplant
Metabolic and CD4+ T Cell Dysregulation in Post-Transplant Diabetes Mellitus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding expired
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (OGTT, euglycemic hyperinsulinemic clamp)
- description
- 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.
- interventionNames
- Procedure: assessment of therapy complications
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Pre-transplant peripheral insulin sensitivity and glucose disposal as defined by the peripheral insulin sensitivity index among patients who do or do not go on to develop PTDM
- timeFrame
- Up to 21 days pre-transplant
- description
- Patients will be followed for 100 days after transplant for development of diabetes. Wilcoxon rank sum test will be applied to compare the population mean difference between these two groups. Multivariable logistic regression will evaluate whether the peripheral insulin sensitivity index is an independent predictor of PTDM after adjusting for the following covariates: fasting C-peptide level, conditioning (ablative vs. reduced intensity), or acute graft-versus-host disease (GVHD) requiring steroids. The estimated odds ratio (OR) and 95% confidence interval of the OR will be provided to measure the effect of the association.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available