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OpenTrials
Completed

NCT Number: NCT02176096

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chrildren's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of GSD Type 1
  • Age >5 years

Exclusion criteria

  • n/a

Treatment and study plan

Glycosade

Dietary Supplement

Other names: Modified starch

Primary outcomes

  1. Normal Blood Glucose

    Time frame: Overnight

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Co-Investigator - Dr. Cheryl Rockman-Greenberg

Registry information

Acronym: Glycosade GSD

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 26, 2014
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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