Glycogen Storage Disease Breath Test Study (NCT03218904) | Clinical Trial Compass
CompletedNot Applicable
Glycogen Storage Disease Breath Test Study
Canada14 participantsStarted 2017-03-17
Plain-language summary
Glycogen storage disease type I (GSD I) caused by deficiency of glucose-6-phosphatase enzyme leading to build up of a complex sugar called glycogen in liver and low blood glucose level. Nutritional treatment involves supplying carbohydrates and uncooked cornstarch. Glycosade® (modified cornstarch) has shown promise in maintaining normal blood glucose level in GSD I. But the difficulty in nutritional treatment is determining the best type of carbohydrate to be given to avoid low blood glucose. Thus, there is a need to develop a simple test to examine glucose digestion and measure the utilization of different carbohydrates in GSD I and healthy controls.
Who can participate
Age range
5 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Experiment 1
* Healthy adults 19 - 35 years of age
* Adults who have no medical conditions
* Adults who currently free from any concurrent illness such as fever or cold
Experiment 2
Healthy Controls:
* Healthy children 5 - 18 years of age
* Healthy adults 19 - 35 years of age
* Children and adults who have no medical conditions
* Children and adults who currently free from any concurrent illness such as fever or cold
Subjects with GSD I:
* Children 5 - 18 years of age who are diagnosed with GSD I
* Adults 19 - 35 years of age who are diagnosed with GSD I
* Clinically stable children and adults with GSD I with no concurrent illness such as fever, cold, vomiting or diarrhea
* Children and adults with GSD I who have had the clinical decision made to start the extended release waxy maize cornstarch Glycosade®
Exclusion Criteria:
Experiment 1
* Healthy adults above age 35 years
* Adults who have a history of cardiovascular disease, liver or kidney disease, metabolic, pulmonary, gastrointestinal or endocrine disorder
* Healthy adults but are currently ill with a fever, cold, vomiting or diarrhea
* Healthy adults with claustrophobia
* Healthy adults currently smoking or consuming more than one drink containing alcohol each day
* Adults currently or recently taking medication or antibiotics
Experiment 2
Healthy Controls:
* Healthy children under age 5 years
* Healthy adults above age 35 years
* Children and adults who have a history of cardiovascular …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.