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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT02359461
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 2 diabetes
* Age between ≥ 18 and ≤ 75 years
* Diagnosis of diabetes\> 2 years
* Asymptomatic on the cardiovascular
* No known heart disease
* ECG in sinus rythm with no signs suggestive of heart disease
* Absence of myocardial ischemia demonstrated by a stress test, myocardial scintigraphy or stress ultrasound
* Oral treatment with antidiabetic and / or insulin and / or incretin
* Affiliated with a social security scheme
* Having signed an informed consent
Exclusion Criteria:
* Type 1 diabetes
* Previous history of cardiomyopathy or ischemic heart disease
* Absence of sinus rythm
* ECG that suggest heart disease
* Electrical malfunction during the exercise test
* Hemo-dynamically significant valvular pathology
* Severe renal impairment (GFR \<30 ml / min / 1.73m²)
* Uncontrolled hypertension: SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg The introduction or modification of antihypertensive treatment leads to the inability to include the subject for two months, the time to reach a new balance.
* Comorbidity involving life-threatening
* BMI\> 40 kg /m2
* Peripheral vascular disease:
* Stage 3
* IPS (Index of systolic pressures) uninterpretable for which a doppler has diagnosed arteritis
* IPS lowered below 0.80
* Proximal or distal arterial bypass (or sub-popliteal fossa) or aortic prosthesis
* Deep vein thrombosis or superficial scalable recent lower limb or having a pulmonary embolism for less than one year
* Unhealed wound of the lower limbs or abdomen (ulcer, saphenectomy scars, surgical scarpa or abdominal approach)
* Disabling painful symptomatology of the lower extremities (paraesthesia, neuropathy, myalgia)
* Treaty by selective phosphodiesterase inhibitor (Sildenafil ...)
* Patients with cognitive impairment disabling
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02359461
Study Brief:
Protocol Section:
NCT02359461