Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT02635269
Eligibility Criteria:
Inclusion Criteria:
* Men and women with genetically and/or biochemically verified LCHAD Deficiency
* Healthy controls needs to be healthy to be included, evaluated by the investigator.
Exclusion Criteria:
* Competing conditions at risk of compromising the results of the study.
* Pregnancy or breastfeeding
* Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise.
* Inability to understand the purpose of the trial or corporate for the conduction of the experiments.
* Veins that are too difficult to puncture for blood sampling or insertion of intravenous catheters, evaluated by the investigator
* Moderate to severe muscle weakness, that prevents the subject completing 10 minutes of cycle-ergometry exercise at 60-70 % of VO2peak, evaluated by the investigator.
* Participation in other trials that may interfere with the results.
* Intake of medications that may interfere with the results or may compromise exercise performance, as evaluated by the investigators.
* Donation of blood within 30 days prior to conduction of the tests on test day 1.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
80 Years
Study:
NCT02635269
Study Brief:
Protocol Section:
NCT02635269