Back to resultsComparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial (Glycosade GSD)
Primary Purpose
Glycogen Storage Disorder Type 1, Hypoglycemia, Cornstarch
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Glycosade
Sponsored by
About this trial
This is an interventional treatment trial for Glycogen Storage Disorder Type 1
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of GSD Type 1
- Age >5 years
Exclusion Criteria:
- n/a
Sites / Locations
- Chrildren's Hospital Research Institute of Manitoba
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glycosade
Arm Description
Outcomes
Primary Outcome Measures
Normal Blood Glucose
With the use of Glycosade blood glucose would be maintained for 8 hours.
Secondary Outcome Measures
Full Information
NCT ID
NCT02176096
First Posted
June 24, 2014
Last Updated
August 2, 2017
Sponsor
University of Manitoba
Collaborators
Co-Investigator - Dr. Cheryl Rockman-Greenberg
1. Study Identification
Unique Protocol Identification Number
NCT02176096
Brief Title
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
Acronym
Glycosade GSD
Official Title
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Co-Investigator - Dr. Cheryl Rockman-Greenberg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glycogen Storage Disorder Type 1, Hypoglycemia, Cornstarch, Glycosade
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glycosade
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Glycosade
Other Intervention Name(s)
Modified starch
Primary Outcome Measure Information:
Title
Normal Blood Glucose
Description
With the use of Glycosade blood glucose would be maintained for 8 hours.
Time Frame
Overnight
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of GSD Type 1
Age >5 years
Exclusion Criteria:
n/a
Facility Information:
Facility Name
Chrildren's Hospital Research Institute of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
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