Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482154
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.

Condition or disease Intervention/treatment
Stem Cell Transplant Complications Hyperglycemia Hypoglycemia Procedure: Hematopoietic Stem Cell Transplant

Detailed Description:
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.

Layout table for study information
Study Type : Observational
Actual Enrollment : 344 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Group/Cohort Intervention/treatment
With Malglycemia Procedure: Hematopoietic Stem Cell Transplant
Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.

Without Malglycemia Procedure: Hematopoietic Stem Cell Transplant
Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.




Primary Outcome Measures :
  1. Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients [ Time Frame: Transplant Day -14 to +100 ]
    hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)

  2. Number of patients with versus without malglycemia who experience infection [ Time Frame: Transplant Day 0 to +100 ]
    It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence


Secondary Outcome Measures :
  1. Determine whether specific exposures are associated with increased occurrence of malglycemia [ Time Frame: Transplant Day -14 to +100 ]
    The occurrence of the outcome, malglycemia, with be assessed for differences in incidence that may occur as a result of age, medication exposures (use of glucocorticoids, asparaginase, total parenteral nutrition (TPN), or calcineurin inhibitors), underlying diagnosis, and transplant type

  2. Survival rate of patients with versus without malglycemia [ Time Frame: Transplant Day 0 through date of relapse or death ]
    It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant mortality. This outcome will be assessed for differences in incidence based on malglycemia occurrence

  3. Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia [ Time Frame: Transplant Day 0 through date of relapse or death ]
    It is hypothesized that patients who experience malglycemia will have an increased rate of GVHD. This outcome will be assessed for differences in incidence based on malglycemia occurrence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who received hematopoietic stem cell transplants with the Bone Marrow Transplant Program at Children's Hospital Colorado from January 1, 2007 to July 31, 2016.
Criteria

Inclusion Criteria:

  • Age 0 to 30 years old at time of transplant
  • Bone Marrow Transplant (BMT) recipient at Children's Hospital Colorado (CHCO) between 1/1/2007 and 7/31/2016

Exclusion Criteria:

  • Preexisting diabetes mellitus or known hyperglycemia
  • Inadequate blood glucose data for analysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482154


Locations
Layout table for location information
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Jenna Sopfe, MD Children's Hospital Colorado

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03482154    
Other Study ID Numbers: 16-1496.cc
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases