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Completed

NCT Number: NCT03513835

Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

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.

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Key information

Conditions

Mitochondrial Myopathies Healthy Controls Metabolic Diseases Mitochondrial Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic screenings tests

Diagnostic Test

Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 2, 2018
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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