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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT06360302
Eligibility Criteria:
Inclusion Criteria:
Group 1: Healthy subjects:
* Postmenopausal women aged 40 to 75 or men aged 40 to 75
* No chronic disease or treatment
* BMI \<30 kg/m², or
* Fasting blood glucose \< 1.10 g/dL
Group 2: metabolic syndrome patients
* Postmenopausal women aged 40 to 75 or men aged 40 to 75
* Metabolic syndrome as defined by the International Diabetes Federation (IDF 2006)5
* BMI \<30 kg/m² and waist circumference \>80 cm for women and \>94 cm for men
* Insulin resistance defined by HOMA-IR\>2.4
Group 3: CKD dialysis patients
* Non-diabetics
* Postmenopausal women aged 40 to 75 and men aged 40 to 75
* BMI \<30 kg/m².
* Chronic kidney disease patients on dialysis - stable on HD for more than 3 months
Patients and healthy subjects will be matched on age (+/-3 years) and sex
Exclusion Criteria:
* Non-stabilized pathology incompatible with physical exercise
* Ongoing exercise retraining program
* Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins, etc.)
* Treatment influencing mitochondrial function (metformin, statin, etc.)
* Failure to obtain written informed consent after a period of reflection
* Subject not affiliated to a social security scheme, or not benefiting from such a scheme.
* Person protected by law (under guardianship or curatorship)
* Patient deprived of liberty
* Diabetic patient
* Family dyslipidemia
* Participants who have reached the maximum amount of compensation for their participation in research projects
* Person under psychiatric care
* Person participating in another research project with an exclusion period still in progress.
* Mentally handicapped, dementia, illiterate, language barrier with inability to understand study purpose and methodology
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06360302
Study Brief:
Protocol Section:
NCT06360302