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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
Sponsor:
Information provided by (Responsible Party):
John Mitchell, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date January 31, 2014
First Posted Date February 4, 2014
Last Update Posted Date September 25, 2015
Study Start Date November 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 23, 2015)		 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.
Original Primary Outcome Measures
 (submitted: February 3, 2014)
  • The aim of the present study is to determine if there is a change in quality 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 determine if there is a change in 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.
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2014)		 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 3, 2014)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch
Official Title A Comparison of Quality of Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard and Modified Uncooked Cornstarch
Brief Summary The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by adults and children with GSD and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if there is a change in quality of life perceived by adults and children and their parents with Glycosade.
Detailed Description This is a prospective cohort study. Patients above 2 years old and their parents (for children only) will be enrolled during their usual follow-up. 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) and a quality of life questionnaire (as it pertains to the child only). Parents will then 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. Adult GSD patients will complete their own questionnaires. Following this first assessment, they will be hospitalised over a 24 hour period as part of standard of care to start the modified UCCS, Glycosade, under supervision and with a continuous glucose monitoring (CGM) sensor. Following hospitalization, the family will return home. Glucose will be monitored with the aid of the CGM sensor for 5 to 7 days. The actigraphy and the sleep diary will be repeated after 2 weeks (for 1 week) while on Glycosade. One month after starting the modified UCCS, questionnaires on quality of sleep and quality of life will be repeated.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Glycogen Storage Disease taking uncooked cornstarch to prevent hypoglycemia followed at the Montreal Children's Hospital and St-Luc Hospital.
Condition
  • Glycogen Storage Disease Type IA
  • Glycogen Storage Disease Type IB
  • Glycogen Storage Disease Type III
  • Glycogen Storage Disease Type 0
Intervention Dietary Supplement: Glycosade
Study Groups/Cohorts Glycosade
A prospective cohort design will be used to assess the impact on sleep and continue to monitor safety of Glycosade.
Intervention: Dietary Supplement: Glycosade
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 23, 2015)		 11
Original Estimated Enrollment
 (submitted: February 3, 2014)		 20
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients of ≥ 2 years old with a diagnostic of GSD 0, I, III, VI, IX or XI based on a liver biopsy, mutation in the appropriate gene or clinical evidence of GSD with a positive familial history
  • Medical history of fasting hypoglycemia
  • Currently taking standard UCCS
  • With a stable condition
  • Followed in GSD clinics at the Montreal Children's Hospital and the Hôpital St-Luc
  • With informed consent obtained

Exclusion Criteria:

  • Continuous overnight feeds
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02054832
Other Study ID Numbers 12-337-PED
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party John Mitchell, McGill University Health Centre/Research Institute of the McGill University Health Centre
Original Responsible Party Same as current
Current Study Sponsor John Mitchell
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: John J Mitchell, MD Montreal Children's Hospital of the MUHC
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date September 2015