Clinical trial · Observational
Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant
Islet Cell and ST2 Axis Dysregulation in Post-Transplant Diabetes Mellitus
NCT03415139CI-TRIAL-00057357unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes Mellitus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2 OGTTs with and without GLP-1 analogue | Drug | — | UNRESOLVED |
| Hyperglycemic clamp procedure | Drug | — | UNRESOLVED |
| Oral Glucose Tolerance Test (OGTT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm 1 for MRD HCT Recipients
- description
- 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.
- interventionNames
- Drug: Oral Glucose Tolerance Test (OGTT)
- Drug: Hyperglycemic clamp procedure
- label
- Arm 2 for MRD HCT Recipients
- description
- 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.
- interventionNames
- Drug: 2 OGTTs with and without GLP-1 analogue
Primary outcomes (6)
- measure
- Pre-transplant insulin secretion will be measured as glucose stimulated insulin secretion (GSIS) during a hyperglycemic clamp procedure among patients who do or do not go on to develop PTDM (univariable analysis).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.