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NCT04929002 Clinical Trial

Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases

Pompe Disease (Late-onset) Clinical Trial

Official title:
Using Carbon-13 Magnetic Resonance Spectroscopy to Assess Whether High Glycogen Levels in Skeletal Muscle of Patients With Glycogen Storage Diseases is a Prelude for Muscle Damage.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04929002
Other study ID # 7TMRS in GSD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 10, 2021
Est. completion date May 2026

Study information
Verified date April 2024
Source Rigshospitalet, Denmark
Contact Mads Stemmerik, MD
Phone 35456126
Email mads.peter.godtfeldt.stemmerik@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The project will use carbon-13 magnetic resonance spectroscopy to assess whether high glycogen levels in skeletal muscle of patients with Glycogen Storage Diseases is a prelude for muscle damage. Patients with Glycogen Storage Diseases will be examined using carbon-13 MR-spectroscopy to quantify the glycogen levels in lumbar, thigh and calf-muscles. The pattern of glycogen concentration will be compared to the pattern of muscle atrophy found in the literature.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date May 2026
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with genetically verified neuromuscular disease or healthy control - Healthy controls needs to be healthy to be included, evaluated by the investigator Exclusion Criteria: - Ferrous objects in or around the body - Pacemaker or other implanted electronic devices - Claustrophobia - Inability to understand the purpose of the trial or corporate for the conduction of the experiments. - Participation in other trials that may interfere with the results. - Competing conditions at risk of compromising the results of the study, evaluated by the investigator. - Strenuous exercise in the preceding 2 days before examination - Pregnancy or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
Denmark Neuromuscular Research Unit, 8077 Copenhagen Copenhange

Sponsors (2)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Danish Research Center for Magnetic Resonance

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycogen concentration The difference in muscle glycogen between patients and controls
The difference in muscle glycogen between different muscle groups in patients.		 Day 1
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