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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT02505451
Eligibility Criteria:
Inclusion Criteria:
* Male and female 40-65 years old, asymptomatic and free of coronary disease
Exclusion Criteria:
* for all the subjects :
* body mass index \> 35 kg / m2, defining severe obesity,
* Under insulin therapy,
* Poorly controlled hypertension (\> 140/95)
* Peripheral vascular disease (\> stage II of Leriche)
* Heart disease or known coronary artery disease,
* Known and poorly compensated thyroid dysfunction,
* Nocturnal apnea syndrome,
* Inability to give written informed consent,
* Chronic diseases,
* moderate to severe left ventricular hypertrophy :\> 109 g / m2 in women and\> 132 g / m2 in men and parietal thickness \> 13mm.
for the diabetic patients only :
* poor glycemic control (HbA1c \> 9%)
* severe autonomic or peripheral neuropathy,
* Severe diabetic retinopathy,
* Advanced Diabetic nephropathy (defined by documented proteinuria and / or renal failure).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02505451
Study Brief:
Protocol Section:
NCT02505451