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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02745938 |
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Date of registration:
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12/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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GDF-15 as a Biomarker for Mitochondrial Disease
GDF-15 |
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Scientific title:
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GDF-15 as a Biomarker for Mitochondrial Disease |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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97 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02745938 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Nanna S. Nielsen, B.Sc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Copenhagen Neuromuscular Center |
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Key inclusion & exclusion criteria
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Criteria for subjects with mitochondrial disease, metabolic myopathy or muscle dystrophy:
Inclusion Criteria:
- Verified mitochondrial disease, metabolic myopathy or muscular dystrophy.
Exclusion Criteria:
- Other muscle disorders.
- Heart failure or significantly reduced kidney or lung function.
- Contraindications for exercise test, e.g. serious heart and lung disease. The
investigator will decide whether or not it is possible for the subject to participate
(Only for the subjects doing an exercise test.).
Criteria for healthy individuals:
Inclusion Criteria:
None (except age > 15 years).
Exclusion Criteria:
- Any muscle disorder
- Heart failure
- Contraindications for exercise test, e.g. serious heart and lung disease. The
investigator will decide whether or not it is possible for the subject to participate
(Only when participating in the exercise test).
Age minimum:
15 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metabolic Myopathy
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Muscular Dystrophy
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Mitochondrial Disease
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Primary Outcome(s)
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GDF-15 concentration in plasma sample at rest.
[Time Frame: One blood sample per subject will be analysed. It takes 5 minutes.]
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Secondary Outcome(s)
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GDF-15 concentration in plasma after exercise
[Time Frame: The exercise test takes half an hour. Blood samples will be taken 1, 2, 3, 24 and 48 hours after the exercise test.]
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Maximal workload capacity (Wmax)
[Time Frame: The test takes half an hour per subject.]
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Maximal oxidative capacity (VO2max)
[Time Frame: The test takes half an hour per subject.]
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Other biomarkers of energy metabolism disorders at rest and after exercise test.
[Time Frame: If the blood samples are only taken at rest, the test takes 5 minutes. If an exercise test is done, it takes 48 hours.]
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Secondary ID(s)
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H-16023953
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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