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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)

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ClinicalTrials.gov Identifier: NCT02176096
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Co-Investigator - Dr. Cheryl Rockman-Greenberg
Information provided by (Responsible Party):
Dr. Aizeddin (Aziz) Mhanni, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Glycogen Storage Disorder Type 1 Hypoglycemia Cornstarch Glycosade Dietary Supplement: Glycosade Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Experimental: Glycosade Dietary Supplement: Glycosade
Other Name: Modified starch




Primary Outcome Measures :
  1. Normal Blood Glucose [ Time Frame: Overnight ]
    With the use of Glycosade blood glucose would be maintained for 8 hours.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of GSD Type 1
  • Age >5 years

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176096


Locations
Canada, Manitoba
Chrildren's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Sponsors and Collaborators
University of Manitoba
Co-Investigator - Dr. Cheryl Rockman-Greenberg

Responsible Party: Dr. Aizeddin (Aziz) Mhanni, Associate Professor, Department of Pediatrics and Child Health, University of Manitoba
ClinicalTrials.gov Identifier: NCT02176096     History of Changes
Other Study ID Numbers: B2013-097
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Hypoglycemia
Glycogen Storage Disease
Glycogen Storage Disease Type I
Glucose Metabolism Disorders
Metabolic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn