Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch
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|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|
|Actual Primary Completion Date :||July 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|