Glycosade® v UCCS in Hepatic GSD (Glyde). Version 2
Research type
Research Study
Full title
A comparison of Glycosade® and Uncooked Cornstarch (UCCS) for the treatment of hepatic glycogen storage diseases (GSD)
IRAS ID
148762
Contact name
Helen Mundy
Contact email
Sponsor organisation
Vitaflo International Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The main clinical feature of Glycogen Storage Disease is low blood sugar after relatively short periods of without food and drink.Patients with GSD have to eat often usually every 3 - 4 hours through the day and night. Thus patients often have to wake up in the middle of the night to have something to eat, drink, have cornstarch or have a tube for feeding overnight.
The aim of dietary management is to keep blood sugar levels in the normal range for as long as possible and improve complications such as blood lipid (fat) levels and growth.
This study is designed to look into and compare the effects of 2 starches: Glycosade® and uncooked corn starch on blood sugar levels, blood insulin and blood ketone levels in a group of children and adults with hepatic GSD types I, III, VI & IX initially.
Longer term there are a number of complications such as bone disease, large liver, development of liver adenomas, poor quality diet, poor sleep patterns and renal disease. The study aims to compare any differences in quality of life, changes in bone structure and composition, changes in dietary patterns, changes in the liver size and number of adenomas (a benign tumour with cells arranged in patterns similar to those of a gland) between the two starches.
REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/0685
Date of REC Opinion
15 Sep 2015
REC opinion
Further Information Favourable Opinion