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

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Brief 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

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

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.
    



Study Type

Interventional


Primary Outcome

Normal Blood Glucose


Condition

Glycogen Storage Disorder Type 1

Intervention

Glycosade

Study Arms / Comparison Groups

 Glycosade
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

4

Start Date

July 2014

Completion Date

August 2, 2017

Primary Completion Date

August 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of GSD Type 1

          -  Age >5 years

        Exclusion Criteria:

          -  n/a
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02176096

Organization ID

B2013-097


Responsible Party

Principal Investigator

Study Sponsor

University of Manitoba

Collaborators

 Co-Investigator - Dr. Cheryl Rockman-Greenberg

Study Sponsor

, , 


Verification Date

August 2017