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Trial record 1 of 1 for:    NCT02318966
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Glycosade v UCCS in the Dietary Management of Hepatic GSD (Glyde)

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ClinicalTrials.gov Identifier: NCT02318966
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : June 11, 2020
Sponsor:
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
Information provided by (Responsible Party):
Vitaflo International, Ltd

Brief Summary:
To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management of hepatic glycogen storage diseases (GSD).

Condition or disease Intervention/treatment Phase
Glycogen Storage Disease Dietary Supplement: Medical Food - Glycosade Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the Dietary Management of Hepatic Glycogen Storage Diseases (GSD)
Actual Study Start Date : February 22, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Glycosade
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.
Dietary Supplement: Medical Food - Glycosade
double blind randomised crossover of 2 starches - glycosade and UCCS

Placebo Comparator: Uncooked corn starch
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.
Dietary Supplement: Medical Food - Glycosade
double blind randomised crossover of 2 starches - glycosade and UCCS




Primary Outcome Measures :
  1. 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 Measures :
  1. 1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®. [ Time Frame: 24 hours ]
  2. 2. The area under the curve in lactate, BOHB, during dietary management with UCCS compared to dietary management with Glycosade®. [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02318966


Locations
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United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
France
Hôpital Antoine Béclère
Clamart, France, 92140 Cedex
Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700RB
United Kingdom
National Hospital for Neurology and Neurosurgery
London, Greater London, United Kingdom, WC1N 3BG
Evelina Children's Hospital
London, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
Sponsors and Collaborators
Vitaflo International, Ltd
University College London Hospitals
University of Florida
Great Ormond Street Hospital for Children NHS Foundation Trust
University Medical Center Groningen
Hôpital Necker-Enfants Malades
Investigators
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Principal Investigator: Helen Mundy, MRCP MRCPCH Guys and St Thomas NHS Foundation Trust
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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02318966    
Other Study ID Numbers: MCTW-GLY-03/14-18
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Glycogen Storage Disease
Metabolic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn