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

NCT ID: NCT02176096

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-08-02

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glycosade

Group Type: EXPERIMENTAL

Glycosade

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Glycosade

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Modified starch

Eligibility Criteria

Inclusion Criteria

• Diagnosis of GSD Type 1
• Age >5 years

Exclusion Criteria

• n/a

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Co-Investigator - Dr. Cheryl Rockman-Greenberg

UNKNOWN

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Aizeddin (Aziz) Mhanni

Associate Professor, Department of Pediatrics and Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chrildren's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2013-097

Identifier Type: -

Identifier Source: org_study_id