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NCT02176096 Clinical 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

Hypoglycemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02176096
Other study ID # B2013-097
Secondary ID
Status Completed
Phase N/A
First received June 24, 2014
Last updated August 2, 2017
Start date July 2014
Est. completion date August 2, 2017

Study information
Verified date August 2017
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date August 2, 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- Diagnosis of GSD Type 1

- Age >5 years

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Glycosade

Locations
Country Name City State
Canada Chrildren's Hospital Research Institute of Manitoba Winnipeg Manitoba

Sponsors (2)
Lead Sponsor Collaborator
University of Manitoba Co-Investigator - Dr. Cheryl Rockman-Greenberg

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Normal Blood Glucose With the use of Glycosade blood glucose would be maintained for 8 hours. Overnight
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