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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05144802
Eligibility Criteria:
Inclusion Criteria: all population
* No history of respiratory diseases (childhood asthma, respiratory allergies, exercise-induced asthma or dyspnea)
* Willing to participate and able to sign an informed consent form (ICF)
* Being affiliated with the French Social Security
Inclusion Criteria:Patients with diabetes
* type 1 diabetes mellitus or type 2 diabetes mellitus (ADA definition)
* Age : 18 to 75 years
* stable diabetes treatment for more than 3 months
* no diabetic retinopathy
* no diabetic neuropathy
* no cardiovascular diseases
* no contra-indication for coronary computed tomography angiography or myocardial perfusion scintigraphy.
Inclusion Criteria: Healthy volunteers
* Age : 18 ; 40 years
* No diabetes
* No persistant drug use \> 3 months except contraception
* Body mass index : \[18,5 - 29,9\] kg/m2
Non-inclusion criteria : all population
* Active smokers
* Pregnant or breastfeeding women, women of childbearing age without effective contraception
* Known allergies to the patch.
* Skin lesions at the sensor site that may interfere with sensor placement or accuracy
* Major cardiovascular complications within the past 3 months
* Decompensated congestive heart failure
* Chronic respiratory failure
* Chronic renal failure
* Resting ambient air O2 saturation ≤95%.
* Treatment with systemic corticosteroids
* Severe hypertension (≥180 mmHg systolic pressure or ≥ 100 mmHg diastolic pressure)
* Any concomitant disease or condition that the investigator believes may compromise patient safety or affect the conduct of the study
* Anemia (Hb\<12g/dl)
* History of severe mountain sickness
* Concurrent participation in another clinical research study,
* Persons benefiting from enhanced protection
Non-inclusion criteria: Patients with diabetes
* Absolute contraindications to physical activity (HAS definitin) :
* Pulmonary arterial hypertension (\> 60 mm Hg)
* Presence of intra-cardiac thrombus
* Acute pericardial effusion
* Severe obstructive cardiomyopathy
* Symptomatic aortic stenosis
* Recent thrombophlebitis with or without pulmonary embolism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05144802
Study Brief:
Protocol Section:
NCT05144802