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MRI in McArdle Disease (GSDV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844022
Recruitment Status : Unknown
Verified November 2019 by Nicoline Løkken, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : February 18, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Nicoline Løkken, Rigshospitalet, Denmark

Study Description
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Brief Summary:
The aim of this study is to describe the degree of muscle wasting in patients with McArdle disease judged by MRI, quantitative magnetic resonance (DIXON) and T1 weighted images, and muscle strength, collected across multiple European sites and compared to healthy controls.

Condition or disease Intervention/treatment
Glycogen Storage Disease Type V Diagnostic Test: MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: MRI in McArdle Disease (Glycogen Storage Disease Type V)
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
McArdle disease
Glycogen storage disease
 Diagnostic Test: MRI
magnetic resonance imaging
Healty controls
Age and gender matched
 Diagnostic Test: MRI
magnetic resonance imaging


Outcome Measures
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Primary Outcome Measures :
  1. DIXON MRI [ Time Frame: 1 time ]
    Whole body quantitative muscle fat fraction analyses (DIXON)


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: 1 time ]
    MRC scale

  2. T1 MRI [ Time Frame: 1 time ]
    Whole body qualitative muscle fat fraction analyses (T1)

  3. Back pain questionnaire [ Time Frame: 1 time ]
    Back pain questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
McArdle disease (GSDV) Healthy controls
Criteria

Inclusion Criteria:

  • GSDV or healthy controls

Exclusion Criteria:

  • MRI contradictions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844022


Locations
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Denmark
Copenhagen Neuromuscular Center, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Nicoline Løkken    +45 3545 8748    nicolineloekken@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Responsible Party: Nicoline Løkken, MD, Research fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03844022    
Other Study ID Numbers: H-18023049.1
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glycogen Storage Disease
Glycogen Storage Disease Type V
Metabolic Diseases
 Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn