Clinical Trial: Glycosade v UCCS in the Dietary Management of Hepatic GSD
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Summary:
'Glyde' is a prospective, randomised double blind crossover trial to compare the effects of 2 different starches used in the dietary management of GSD.
The study will recruit 64 patients from approximately 6 centres in the UK, USA, France and The Netherlands. The planned duration per participant is 2 years.
Participants will be randomised into 2 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.
Sponsor: Vitaflo International, Ltd
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Vitaflo International, Ltd
Dates:
Date Received: December 12, 2014
Date Started: February 2016
Date Completion: December 2019
Last Updated: April 13, 2017
Last Verified: April 2017
