Glycogen Storage DiseaseGlydeNCT02318966
Glycosade v UCCS in the Dietary Management of Hepatic GSD
A study testing Medical Food - Glycosade in people with Glycogen Storage Disease, run by Vitaflo International, Ltd at 6 sites in 4 countries.
Trial summary
To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management of hepatic glycogen storage diseases (GSD). Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Glycogen Storage Disease
- What is being tested?
- Medical Food - Glycosade
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 22 Feb 2016to 14 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United Kingdom3 sites
National Hospital for Neurology and Neurosurgery
London, Greater London, WC1N 3BG
Evelina Children's Hospital
London
Great Ormond Street Hospital for Children
London
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Netherlands1 site
Universitair Medisch Centrum Groningen
Groningen, 9700RB
About this study
Official title: A Comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the Dietary Management of Hepatic Glycogen Storage Diseases (GSD)
To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management of hepatic glycogen storage diseases (GSD).
Read the 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.
- Conditions
- Glycogen Storage Disease
- Being tested
- Medical Food - Glycosade
- Medical subject headings
- Glycogen Storage Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food - GlycosadeDietary supplement
double blind randomised crossover of 2 starches - glycosade and UCCS
| Study group | Role | What they receive |
|---|---|---|
| Glycosade | Active comparator | 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. Receives: Dietary Supplement: Medical Food - Glycosade |
| Uncooked corn starch | Placebo comparator | 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. Receives: Dietary Supplement: Medical Food - Glycosade |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (2)
1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®.
Measured: 24 hours
2. The area under the curve in lactate, BOHB, during dietary management with UCCS compared to dietary management with Glycosade®.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study start22 Feb 2016
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycogen Storage DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Helen Mundy, MRCP MRCPCH, Principal investigator, Guys and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318966
- Sponsor's protocol ID
- MCTW-GLY-03/14-18
- Acronym
- Glyde
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2014
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weinstein DA, Jackson RJ, Brennan EA, Williams M, Davison JE, Boer F, Derks T, Ellerton C, Faragher B, Gribben J, Labrune P, McKittrick KM, Murphy E, Ross KM, Steuerwald U, Voillot C, Woodward A, Mundy HR. Short and long-term acceptability and efficacy of extended-release cornstarch in the hepatic glycogen storage diseases: results from the Glyde study. Orphanet J Rare Dis. 2024 Jul 9;19(1):258. doi: 10.1186/s13023-024-03274-y.
PubMed 38982397
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the Dietary Management of Hepatic Glycogen Storage Diseases (GSD)
- ClinicalTrials.gov ID
- NCT02318966
- Acronym / sponsor ID
- Glyde / MCTW-GLY-03/14-18
- Conditions
- Glycogen Storage Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- 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
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycosade | Active comparator | Dietary Supplement: Medical Food - GlycosadeParticipants 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. |
| Uncooked corn starch | Placebo comparator | Dietary Supplement: Medical Food - GlycosadeParticipants 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. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Food - Glycosadedouble blind randomised crossover of 2 starches - glycosade and UCCS | Dietary supplement | Glycosade, Uncooked corn starch |
Primary outcome
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
2 secondary outcomes
1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®.
Time frame: 24 hours
2. The area under the curve in lactate, BOHB, during dietary management with UCCS compared to dietary management with Glycosade®.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 38982397Weinstein DA, Jackson RJ, Brennan EA, Williams M, Davison JE, Boer F, Derks T, Ellerton C, Faragher B, Gribben J, Labrune P, McKittrick KM, Murphy E, Ross KM, Steuerwald U, Voillot C, Woodward A, Mundy HR. Short and long-term acceptability and efficacy of extended-release cornstarch in the hepatic glycogen storage diseases: results from the Glyde study. Orphanet J Rare Dis. 2024 Jul 9;19(1):258. doi: 10.1186/s13023-024-03274-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Mundy, MRCP MRCPCH principal investigator
Guys and St Thomas NHS Foundation Trust
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Food - Glycosade in people with Glycogen Storage Disease, run by Vitaflo International, Ltd at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, United States, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.