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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT06846034
Eligibility Criteria:
Inclusion Criteria:
For all participant :
1. No history of respiratory diseases
2. Affiliated person or beneficiary of the French social security scheme.
3. signed informed consent
Group 1 ( For healthy volunteers):
1. \[18; 40\] years old
2. No history of diabetes
3. No acute/long term \> 3 months drug use except contraception
4. BMI: \[18,5 - 29,9\]kg/m2
5. eGFR \> 60ml/min/1.73m2
6. Normal to midly increased albuminuria: defined as ACR \< 3 mg/mmol
For all the patients with T2D (group 2 and 3):
1. Diagnosed T2D according to ADA criteria
2. \[35; 75\] years old
3. Stable treatment of diabetes and/or antihypertension for at least 2 months prior to inclusion
4. No proliferative diabetic retinopathy
Group 2 - For patients with T2D and no DKD:
* eGFR \> 60ml/min/1.73m2 and
* Normal to midly increased albuminuria: defined as ACR \< 3 mg/mmol
Group 3 - For patients with DKD:
* eGFR \[45-60 ml/min/1.73m2\] and/or
* Moderately to severely increased ACR ≥ 3 mg/mmol
Exclusion Criteria:
For all participants:
1. Active smoking
2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.
3. Contraindication to cardiac MRI, renal MRI, respiratory tests,
4. History acute coronary syndrome or coronary revascularization
5. Recent (\<6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder
6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
7. Resting oxygen saturation \<95% at baseline
8. Any concomitant disease or condition that may interfere with the safety or the possibility for the patient to comply with or complete the study protocol.
9. History of severe mountain sickness (dizziness, headache, nausea/vomiting and incapaciting fatigue)
10. Consumption of SGLT2 inhibitors
11. Concurrent participation in another clinical research study
12. Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
13. Persons benefiting from enhanced protection under french national law
14. Persons under psychiatric care who are unable to give their consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06846034
Study Brief:
Protocol Section:
NCT06846034