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Clinical Trials/NCT02635321
NCT02635321
Completed
Not Applicable

MRI and Muscle Involvement in Patients With Mutations in GMPPB

Rigshospitalet, Denmark1 site in 1 country4 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Limb-girdle Muscular Dystrophy
Sponsor
Rigshospitalet, Denmark
Enrollment
4
Locations
1
Primary Endpoint
MRI scan for qualitative analysis of muscle involvement
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Limb girdle muscular dystrophies (LGMD) are a very heterogeneous group of muscle disorders characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into more than 31 different types.

A new type - type 2T has been found. The genetic cause of type 2T is mutations in Guanosine Diphosphate (GDP)-mannose pyrophosphorylase B (GMPPB). Mutations in GMPPB can also cause Congenital muscular dystrophies (CMD). Only 41 patients with mutations in GMPPB has been reported.

In this study, the investigators examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle involvement using MRI.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
April 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sofie Thurø Østergaard

Bachelor of Science

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Persons with genetically verified mutations in GMPPB

Exclusion Criteria

  • All contraindications for undergoing an MRI scan

Outcomes

Primary Outcomes

MRI scan for qualitative analysis of muscle involvement

Time Frame: One MRI scan per subject (exam lasts approximately 60 min.)

The MRI protocol include T1-weighted brain and whole body examination. Four cross-sectional slices at shoulder, lumbar back, thigh and calf are chosen for qualitative analysis using the grading scale developed by Mercuri et al. (2007).

Secondary Outcomes

  • Muscle biopsy for biochemical investigation(One muscle biopsy per subject (last approximately 15 min.))
  • 10 meter walk test(Exam last approximately 5 min.)
  • Neurological examination and test of muscle strength(Exam last approximately 15 min.)
  • Questionnaires(Data will be collected once for patients with LGMD 2T (exam last approximately 45 min.))
  • Heart examination(Exam last approximately 45 min)
  • Forced Vital Capacity (FVC)(Exam last approximately 15 min)
  • Electromyography (EMG)(Exam last approximately 30 min)

Study Sites (1)

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