NCT02362685

Brief Summary

Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2008Dec 2027

Study Start

First participant enrolled

September 1, 2008

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

19.3 years

First QC Date

February 4, 2015

Last Update Submit

January 21, 2020

Conditions

Keywords

Metabolic myopathiesExercise testingBlood sampleMuscle biopsyGenetic analysisCycloergometerGrip-testExercise physiologyMuscle physiology

Outcome Measures

Primary Outcomes (3)

  • Whole-body dynamic exercise

    The relation between Cardiopulmonary exercise test variables and the results of muscle biopsy or genetic analysis will be evaluated.

    Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed

  • Grip-test

    The relation between Grip-test variables and the results of muscle biopsy or genetic analysis will be evaluated.

    Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed

  • Blood tests

    The results of blood analysis from samples performed before, during, and after exercise will be compared to the results of muscle biopsy or genetic analysis.

    Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed

Study Arms (1)

metabolic exercise testing

All the subjects referred to performed a metabolic exercise testing.

Device: functional testGenetic: matching genotype with phenotype

Interventions

subjects perform a metabolic exercise testing

metabolic exercise testing
metabolic exercise testing

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred to perform a metabolic exercise testing.

You may qualify if:

  • Referred to the Physiology Department of Brest Hospital for a metabolic exercise test
  • Ability to provide informed consent

You may not qualify if:

  • Contraindication(s) to perform cardiopulmonary exercise testing (ATS/ACCP statement on cardiopulmonary exercise testing, Am J respi Care Med 167: 211-77, 2003)
  • Pregnancy or unknown pregnancy status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Brest, 29609, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample Urine sample Muscle tissue DNA

MeSH Terms

Conditions

Myalgia

Interventions

Phenotype

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Fabrice Rannou, MD, PhD

    CHRU Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice Rannou, MD, PhD

CONTACT

Fabrice Rannou, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 13, 2015

Study Start

September 1, 2008

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations