The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases (NCT03871673) | Clinical Trial Compass
CompletedNot Applicable
The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases
Brazil11 participantsStarted 2017-04-29
Plain-language summary
Hepatic Glycogen Storage Diseases are a group of 10 serious genetic diseases that present in childhood and are characterized more frequently by the occurrence of repetitive hypoglycemia and dyslipidemia. Regarding treatment, the most commonly used strategy is the frequent administration of uncooked cornstarch, in average, every 4 hours. Although this treatment is successful, the use of large amounts of cornstarch can lead to overweight and, especially, to the decrease in the quality of life of patients and caregivers, due to the need to use the starch during the night. The search for a treatment that is widely available and that can lead to the prolongation of the fasting time, can collaborate to improve the care of these patients. The main scientific question to be answered by this research is: does sweet manioc starch, a Brazilian product, safely prolong the fasting time (with normoglycemia) of the patients as already suggested in experimental models? Main objective: To evaluate the efficacy and safety of the use of uncooked Sweet Manioc Starch in the treatment of patients with hepatic Glycogen Storage Diseases, using as model the Glycogen Storage Diseases type Ia.
Who can participate
Age range
16 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:
* patients with a confirmed molecular diagnosis of glycogen storage disease type Ia who are already on uncooked cornstarch therapy
Exclusion Criteria:
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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.
1This trial tested uncooked sweet manioc starch as a treatment for Glycogen Storage Disease Type I — how does this starch compare to the cornstarch my child or I am already using, and is there any published data from this completed trial showing whether it kept blood sugar stable for longer?
2The trial measured 'duration of normoglycemia' as its main outcome — based on what you know about the results, did the manioc starch actually extend the time patients stayed in a normal blood sugar range compared to what we're doing now?
3Since this trial is listed as Phase NA and has already been completed, what does that mean for how confident we can be in the safety and effectiveness of manioc starch, and would switching to it be considered an experimental step or something more established?
4Sourcing and preparing the right type of starch is really important for managing GSD Type I — if we wanted to try uncooked sweet manioc starch, how would we reliably get it, and are there any preparation differences from cornstarch that could affect how well it works?
5Given that this trial is now complete, are there any follow-up studies or updated treatment guidelines coming out of it that we should be watching for before deciding whether this approach might be worth discussing as part of my treatment plan?
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.