Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

Healthy Controls Clinical Trial

Official title:

Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513835
• Other study ID #: H-17032512
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Controls
• Mitochondrial Myopathies
• Muscular Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lactate / pyruvate ratio	Changes between: before, during and after submaximal exercise	1 hour
Primary	Serum Acyl-carnitine levels	Changes between: before and after exercise, fasted and fed.	1 hour
Primary	Serum GDF-15	Changes between: before and after exercise, fasted and fed.	1 hour