Cancer Clinical Trial
Official title:
Islet Cell and ST2 Axis Dysregulation in Post-Transplant Diabetes Mellitus
NCT number | NCT03415139 |
Other study ID # | VICC CTT 1836 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 12, 2019 |
Est. completion date | April 2025 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 2025 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | A hyperglycemic clamp procedure will be performed pre-transplant. Pre-transplant will be defined as no more than 28 days before allogeneic hematopoietic cell transplantation. Patients will then be followed for 100 days after transplant for development of diabetes. In univariable analysis, a Wilcoxon rank sum test will be applied to compare the population mean difference in GSIS between these two groups. | Up to 28 days pre-transplant | |
Primary | 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 (multivariable analysis). | A hyperglycemic clamp procedure will be performed pre-transplant. Pre-transplant will be defined as no more than 28 days before allogeneic hematopoietic cell transplantation. Patients will then be followed for 100 days after transplant for development of diabetes. In multivariable analysis, logistic regression will evaluate whether GSIS is an independent predictor of PTDM after adjusting for the following covariates: gender, 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. | Up to 28 days pre-transplant | |
Primary | Post-transplant glucagon secretion will be measured during the oral glucose tolerance test among patients who do or do not develop PTDM (univariable analysis). | Patients will be followed for 100 days after transplant for development of diabetes. In univariable analysis, a Wilcoxon rank sum test will be applied to compare the population mean difference in glucagon secretion between these two groups. | Up to 100 days after transplant | |
Primary | Post-transplant glucagon secretion will be measured during the oral glucose tolerance test among patients who do or do not develop PTDM (multivariable analysis). | Patients will be followed for 100 days after transplant for development of diabetes. In multivariable analysis, a logistic regression will evaluate whether glucagon secretion is independently associated with PTDM after adjusting for the following covariates: gender, 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. | Up to 100 days after transplant | |
Primary | Plasma IL-33 levels will be measured among patients who do or do not develop PTDM (univariable analysis). | Patients will be followed for 100 days after transplant for development of diabetes. In univariable analysis, a Wilcoxon rank sum test will be applied to compare the population mean difference in IL-33 between these two groups. | Up to 100 days after transplant | |
Primary | Plasma IL-33 levels will be measured among patients who do or do not develop PTDM (multivariable analysis). | In multivariable analysis, logistic regression will evaluate whether IL-33 is independently associated with PTDM after adjusting for the following covariates: gender, 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. | Up to 100 days after transplant |
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