Glycosade v UCCS in the Dietary Management of Hepatic GSD

Glycogen Storage Disease Clinical Trial

— Glyde  

Official title:

A Comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the Dietary Management of Hepatic Glycogen Storage Diseases (GSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318966
• Other study ID #: MCTW-GLY-03/14-18
• Status: Completed
• Phase: N/A
• Start date: February 22, 2016
• Est. completion date: August 14, 2020

Study information

• Verified date: February 2024
• Source: Vitaflo International, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 14, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycogen Storage Disease

Intervention

Dietary Supplement:
• Medical Food - Glycosade
double blind randomised crossover of 2 starches - glycosade and UCCS

Locations

Country	Name	City	State
France	Hôpital Antoine Béclère	Clamart
Netherlands	Universitair Medisch Centrum Groningen	Groningen
United Kingdom	Evelina Children's Hospital	London
United Kingdom	Great Ormond Street Hospital for Children	London
United Kingdom	National Hospital for Neurology and Neurosurgery	London	Greater London
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (6)

Lead Sponsor	Collaborator
Vitaflo International, Ltd	Great Ormond Street Hospital for Children NHS Foundation Trust, Hôpital Necker-Enfants Malades, University College London Hospitals, University Medical Center Groningen, University of Florida

Countries where clinical trial is conducted

United States,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 hours
Secondary	1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®.		24 hours
Secondary	2. The area under the curve in lactate, BOHB, during dietary management with UCCS compared to dietary management with Glycosade®.		24 hours