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Glycosade v UCCS in the Dietary Management of Hepatic GSD (Glyde)

Primary Purpose

Glycogen Storage Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medical Food - Glycosade
Sponsored by
Vitaflo International, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glycogen Storage Disease

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). For those whom mutation analysis is not completed this will be assessed during the study.
  • Aged 2 years or older (5 years or older in the USA)
  • Established on full intake of uncooked corn starch therapy for at least 6 months

Exclusion Criteria:

  • Women who are pregnant or breastfeeding at the start of the study or planning to become pregnant during the study will be excluded.
  • children less than 2 years of age

Sites / Locations

  • Connecticut Children's Medical Center
  • Hôpital Antoine Béclère
  • Universitair Medisch Centrum Groningen
  • National Hospital for Neurology and Neurosurgery
  • Evelina Children's Hospital
  • Great Ormond Street Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Glycosade

Uncooked corn starch

Arm Description

Participants will be randomised to receive the medical food Glycosade as a starch load with a maximum dose of 100g. Glycosade to be taken as one dose.

Participants will be randomised to receive uncooked corn starch as a starch load with a maximum dose of 100g. Uncooked corn starch to be taken as one dose.

Outcomes

Primary Outcome Measures

To assess if Glycosade® will result in improved blood glucose, lactate and ketone levels in a larger group of patients with GSD I, III, VI & IX as measured by duration of normal blood glucose levels or prevention of ketosis

Secondary Outcome Measures

1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®.
2. The area under the curve in lactate, BOHB, during dietary management with UCCS compared to dietary management with Glycosade®.

Full Information

First Posted
December 12, 2014
Last Updated
September 10, 2021
Sponsor
Vitaflo International, Ltd
Collaborators
University College London Hospitals, University of Florida, Great Ormond Street Hospital for Children NHS Foundation Trust, University Medical Center Groningen, Hôpital Necker-Enfants Malades
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1. Study Identification

Unique Protocol Identification Number
NCT02318966
Brief Title
Glycosade v UCCS in the Dietary Management of Hepatic GSD
Acronym
Glyde
Official Title
A Comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the Dietary Management of Hepatic Glycogen Storage Diseases (GSD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
August 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitaflo International, Ltd
Collaborators
University College London Hospitals, University of Florida, Great Ormond Street Hospital for Children NHS Foundation Trust, University Medical Center Groningen, Hôpital Necker-Enfants Malades

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management of hepatic glycogen storage diseases (GSD).
Detailed Description
'Glyde' is a prospective, randomised, double-blind, crossover trial to compare the effects of two different starches used in the dietary management of GSD. The study will recruit 64 patients from six centres in the UK, USA, France and The Netherlands. The planned duration per participant is 2 years. Participants will be randomised into two equally sized groups: Arm A- Glycosade intake given first, followed by UCCS 1-6 weeks later Arm B- UCCS intake given first, followed by Glycosade 1-6 weeks later. The objective of this trial is to establish whether Glycosade® improves outcomes for patients with GSD compared to UCCS therapy by comparing the duration of normal blood sugars, lactate and ketone levels of patients with hepatic GSD (Types I, III, VI and IX) post equivalent intakes of UCCS and Glycosade®. The first part consists of two (blinded) 12 hour starch load tests administered randomly within a maximum 6 week period. Participants will be randomised to receive either UCCS or Glycosade® for the initial intervention period crossing over to the other product for the second intervention period (part 1). The second part (unblinded) is a 24 month open follow up whereby participant's will continue on the product considered most suitable by the clinician and patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glycogen Storage Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycosade
Arm Type
Active Comparator
Arm Description
Participants will be randomised to receive the medical food Glycosade as a starch load with a maximum dose of 100g. Glycosade to be taken as one dose.
Arm Title
Uncooked corn starch
Arm Type
Placebo Comparator
Arm Description
Participants will be randomised to receive uncooked corn starch as a starch load with a maximum dose of 100g. Uncooked corn starch to be taken as one dose.
Intervention Type
Dietary Supplement
Intervention Name(s)
Medical Food - Glycosade
Intervention Description
double blind randomised crossover of 2 starches - glycosade and UCCS
Primary Outcome Measure Information:
Title
To assess if Glycosade® will result in improved blood glucose, lactate and ketone levels in a larger group of patients with GSD I, III, VI & IX as measured by duration of normal blood glucose levels or prevention of ketosis
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®.
Time Frame
24 hours
Title
2. The area under the curve in lactate, BOHB, during dietary management with UCCS compared to dietary management with Glycosade®.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). For those whom mutation analysis is not completed this will be assessed during the study. Aged 2 years or older (5 years or older in the USA) Established on full intake of uncooked corn starch therapy for at least 6 months Exclusion Criteria: Women who are pregnant or breastfeeding at the start of the study or planning to become pregnant during the study will be excluded. children less than 2 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Mundy, MRCP MRCPCH
Organizational Affiliation
Guys and St Thomas NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140 Cedex
Country
France
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Facility Name
National Hospital for Neurology and Neurosurgery
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Evelina Children's Hospital
City
London
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Glycosade v UCCS in the Dietary Management of Hepatic GSD

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