RecruitingNot Applicable

Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I

Switzerland20 participantsStarted 2025-04-24

Plain-language summary

The present project will specifically assess metabolic effects of dietary interventions with controlled intake of fructose and fructose/galactose in GSDI, with the aim to provide evidence whether relaxed dietary restrictions of fructose and galactose may be justified in treatment recommendations at least for adults, which would considerably enlarge food choice in everyday life of the patients with an expected positive impact on the quality of life of patients with this rare disorder.

Who can participate

Age range

18 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: * Genetically and/or enzymatically confirmed diagnosis of GSDI (GSDIa or GSDIb) * Male or female ≥ 18y * Restriction of fructose intake in usual dietary treatment * Written informed consent Exclusion Criteria: * Non-compliance with routine dietary treatment * Pregnancy or lactation * Liver transplant * Recurrent hospitalisations due to metabolic decompensation within the last 12 months * Severe chronic kidney disease with glomerular filtration rate (GFR) \< 30 ml/min * For GSDIb: Severe, uncontrolled symptomatic inflammatory bowel disease

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.

What they're measuring

Change in lactate during the dietary intervention compared to baseline under the usual diet

Timeframe: 4 Weeks

Trial details

NCT IDNCT06852612

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Michel Hochuli, MD, PhD

+41 31 664 03 18 michel.hochuli@insel.ch

View on ClinicalTrials.gov More Glycogen Storage Disease Type I trials