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Recruiting NCT06852612

NCT06852612 Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I

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Clinical Trial Summary
NCT ID NCT06852612
Status Recruiting
Phase —
Sponsor Insel Gruppe AG, University Hospital Bern
Condition Glycogen Storage Disease Type I
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2025-04-24
Primary Completion 2027-03

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
FructoseFructose and galactose

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2025-04-24 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Michel Hochuli, MD, PhD

✉ michel.hochuli@insel.ch

📞 +41 31 664 03 18

Principal Investigator

Michel Hochuli, MD, PhD

PRINCIPAL INVESTIGATOR

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Frequently Asked Questions

Who can join the NCT06852612 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Glycogen Storage Disease Type I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06852612 currently recruiting?

Yes, NCT06852612 is actively recruiting participants. Contact the research team at michel.hochuli@insel.ch for enrollment information.

Where is the NCT06852612 trial being conducted?

This trial is being conducted at Bern, Switzerland, Zurich, Switzerland.

Who is sponsoring the NCT06852612 clinical trial?

NCT06852612 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Michel Hochuli, MD, PhD at Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism. The trial plans to enroll 20 participants.

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