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Trial record 4 of 616 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

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ClinicalTrials.gov Identifier: NCT03513835
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nicoline Løkken, Rigshospitalet, Denmark

Brief Summary:
The purpose of this study is to develop simple diagnostic screeningtests and investigate potential biomarkers for identifying patients with abnormalities of mitochondrial function, which also can be used as outcome measures in future clinical trials. The study will investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with mitochondrial myopathy.

Condition or disease Intervention/treatment
Mitochondrial Myopathies Diagnostic Test: Diagnostic screenings tests

Study Type : Observational
Estimated Enrollment : 60 participants
Official Title: Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders


Intervention Details:
  • Diagnostic Test: Diagnostic screenings tests
    Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.


Primary Outcome Measures :
  1. Serum lactate / pyruvate ratio [ Time Frame: 1 hour ]
    Changes between: before, during and after submaximal exercise

  2. Serum Acyl-carnitine levels [ Time Frame: 1 hour ]
    Changes between: before and after exercise, fasted and fed.

  3. Serum GDF-15 [ Time Frame: 1 hour ]
    Changes between: before and after exercise, fasted and fed.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Genetically verified primary Mitochondrial disorder with myopathy.
Criteria

Inclusion Criteria:

  • age 18-75
  • verified mitochondrial myopathy
  • or healthy control
  • or disease control (another neuromuscular disease)

Exclusion Criteria:

  • Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
  • Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction
  • Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.
  • Pregnancy or breastfeeding.

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): NCT03513835


Contacts
Contact: Nicoline Løkken, MD +45 3545 8748 Nicoline.Loekken@regionh.dk

Locations
Denmark
Copenhagen Neuromuscular Center, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Nicoline Løkken    +45 3545 8748      
Sponsors and Collaborators
Rigshospitalet, Denmark

Responsible Party: Nicoline Løkken, MD, PhD-student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03513835     History of Changes
Other Study ID Numbers: H-17032512
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Muscular Diseases
Mitochondrial Myopathies
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Mitochondrial Diseases
Metabolic Diseases