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

NCT02176096 | Completed DMC

• 1 other identifier: B2013-097
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycogen Storage Disorder Type 1; Hypoglycemia; Cornstarch; Glycosade

Outcome Measures

Primary Outcomes (1)

• Normal Blood Glucose

  With the use of Glycosade blood glucose would be maintained for 8 hours.

  Overnight

Study Arms (1)

Glycosade

EXPERIMENTAL

Dietary Supplement: Glycosade

Interventions

Glycosade DIETARY_SUPPLEMENT

Also known as: Modified starch

Glycosade

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of GSD Type 1
• Age \>5 years

You may not qualify if:

• n/a

Sponsors & Collaborators

• University of Manitoba: lead
• Co-Investigator - Dr. Cheryl Rockman-Greenberg: collaborator

Study Sites (1)

Chrildren's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

octenyl succinic anhydride-modified starch

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics and Child Health

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 2, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

CA (1)