Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch
|ClinicalTrials.gov Identifier: NCT02054832|
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 25, 2015
|Condition or disease||Intervention/treatment|
|Glycogen Storage Disease Type IA Glycogen Storage Disease Type IB Glycogen Storage Disease Type III Glycogen Storage Disease Type 0||Dietary Supplement: Glycosade|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||A Comparison of Quality of Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard and Modified Uncooked Cornstarch|
|Study Start Date :||November 2013|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
A prospective cohort design will be used to assess the impact on sleep and continue to monitor safety of Glycosade.
|Dietary Supplement: Glycosade|
- The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by GSD adults and children and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycaemia. [ Time Frame: 2 weeks ]Parents will be asked to complete a quality of sleep questionnaire (as it pertains to both child and parent) relating to the past month on their current dietary regimen (standard UCCS). Parents will also complete a sleep diary (for both child and parent) and both child and parent will wear an actigraph that will record movements during sleep over a 1 week period prior to Glycosade. The actigraphy and the sleep diary will be repeated after 2 weeks (for 2 weeks) while on Glycosade. The quality of sleep questionnaire will be repeated after 1 month on Glycosade. Adult GSD patients will complete their own questionnaires.
- To evaluate if there is a change in quality of life perceived by GSD adults and children and their parents with Glycosade. [ Time Frame: 1 month ]Parents (as it pertains to their child) and adult patients will be asked to complete quality of life questionnaire prior to Glycosade and 1 month after starting this new diet.
- To describe the variability in glucose fluctuations with Glycosade using a CGM sensor. [ Time Frame: 1 week ]Glucose will be monitored with the aid of the CGM sensor for 5 to 7 days while starting Glycosade.
- To establish if metabolic control is maintained using Glycosade. [ Time Frame: 24 hours ]Metabolic control in hospital after starting Glycosade will be defined as the absence of deterioration of biochemical data at the end of fast compared to during the fast.
- To evaluate the safety profile of Glycosade, based on the frequency of side effects, e.g. gastrointestinal side effects while receiving Glycosade. [ Time Frame: 1 month ]Subjects will be constantly monitored for adverse events throughout the study. They will be asked to keep a diary to document side effects while receiving Glycosade. They will also be asked at each visit whether they experienced any known or unknown side effects.
- To assess the acceptability/palatability of Glycosade. [ Time Frame: 1 month ]Patient report (or parent report on behalf of child) of palatability at 4 weeks after starting Glycosade compared to their previous regimen.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054832
|Montreal Children's hospital|
|Montreal, Quebec, Canada, H3H1P3|
|Principal Investigator:||John J Mitchell, MD||Montreal Children's Hospital of the MUHC|