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 (Glycosade GSD)

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia; Glycogen Storage Disorder Type 1; Cornstarch; Glycosade
• Intervention / Treatment: Dietary supplement: Glycosade

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Chrildren's Hospital Research Institute of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of GSD Type 1
• Age >5 years

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Glycosade	Dietary supplement: Glycosade; Other Names: Modified starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal Blood Glucose	With the use of Glycosade blood glucose would be maintained for 8 hours.	Overnight

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Co-Investigator - Dr. Cheryl Rockman-Greenberg

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 2, 2017

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (ESTIMATE): June 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Disease; Hypoglycemia; Glycogen Storage Disease; Glycogen Storage Disease Type I
• Other Study ID Numbers: B2013-097