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RecruitingNCT06616545Updated Sep 27, 2024

French Observatory for Patients with Type 3 Glycogenosis

An observational study in Glycogen Storage Disease Type III, sponsored by Institut de Myologie, France. Recruiting at 3 sites in France. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Institut de Myologie, France · Observational

From the registry’s dates

  • Started Sep 2013; still recruiting 13 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Sex
All
01

Study summary

Glycogen storage disease type III (GSD-III) or Cori/Forbes disease, is caused by autosomal recessive mutations in the AGL gene, which codes for the glycogen debranching enzyme (GDE) involved in the release of glucose-1P from glycogen branches. Abnormal glycogen accumulation is responsible for frequent hypoglycaemia and symptoms in the liver and striated muscles (GSD-IIIa), although some patients present with liver involvement only (GSD-IIIb). In childhood, the phenotype is mainly characterised by hepatomegaly, short stature and hypoglycaemia, with minimal skeletal muscle involvement. While liver symptoms improve spontaneously around puberty, skeletal muscle weakness develops progressively in adulthood and becomes a major feature of GSD-IIIa.

Currently, there is no treatment other than dietary management tailored to the individual to limit glycogen storage and avoid hypoglycaemia.

The French GSD-III registry is a multicentre online registry dedicated to patients with type III glycogen storage disease followed in France. It has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic AGL gene mutation and/or reduced glycogen debranching enzyme activity.

The aims of the registry are to provide a tool for recording detailed diagnostic, metabolic, neurological, cardiac and biological data on French patients with GSD-III, so as to enable i) a precise natural history of the disease, ii) identification of the outcome measures most sensitive to disease progression, iii) assessment of the frequency of the various complications of the disease and iv) identification of prognostic factors.

02

Conditions studied

  • Glycogen Storage Disease Type III
03

In context

Lead sponsor

Institut de Myologie, France is the lead sponsor of 30 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

GSD type 3 patients from French national reference centres

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with molecularly characterised Glycogen Storage Disease Type III

Exclusion criteria

Exclusion Criteria:

  • Patients diagnosed with GSD type 3 refusing to take part in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Glycogen Storage Disease Type III
06

What researchers measure

Primary outcomes

  1. Fasting period

    Measuring changes in the duration of the fasting period

    Time frame: Through study completion, an average of 10 years

Secondary outcomes

  1. 6MWT distance

    Measurement of changes in distance covered in the 6-minute walk test.

    Time frame: Through study completion, an average of 10 years

07

Study locations

3 of 3 sites recruiting
  • Aphp Antoine Beclere
    Clamart, 92140, France
    Recruiting
  • CHU du Kremlin-Bicêtre
    Le Kremlin-Bicêtre, 94270, France
    Recruiting
    • Antoine GARDIN, MD - PhD · Contact+33 1 45 21 31 69
  • Institue of Myology
    Paris, 75013, France
    Recruiting
08

References and documents

Publications

  • Hogrel JY, Fer F, Ledoux I, Petit F, Darce-Bello M, Labrune P, Wahbi K, Habes D, Gardin A, Masingue M, Laforet P, Decostre V. Prospective gait analysis in patients from the French registry of glycogen storage disease type III: implications for clinical trials. J Neurol. 2026 May 4;273(5):301. doi: 10.1007/s00415-026-13793-2. PubMed 42082675 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06616545
Lead sponsor
Institut de Myologie, France
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
Sep 1, 2013
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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