Glycosade v UCCS in the Dietary Management of Hepatic GSD

Brief Title

Glycosade v UCCS in the Dietary Management of Hepatic GSD

Official Title

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

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.
    


Study Type

Interventional


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

Secondary Outcome

 1. The insulin area under the curve during dietary management with UCCS compared to dietary management with Glycosade®.

Condition

Glycogen Storage Disease

Intervention

Medical Food - Glycosade

Study Arms / Comparison Groups

 Glycosade
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

62

Start Date

February 22, 2016

Completion Date

August 14, 2020

Primary Completion Date

August 14, 2020

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
      

Gender

All

Ages

2 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Helen Mundy, MRCP MRCPCH, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02318966

Organization ID

MCTW-GLY-03/14-18


Responsible Party

Sponsor

Study Sponsor

Vitaflo International, Ltd

Collaborators

 University College London Hospitals

Study Sponsor

Helen Mundy, MRCP MRCPCH, Principal Investigator, Guys and St Thomas NHS Foundation Trust


Verification Date

March 2021