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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04353869
Eligibility Criteria:
Inclusion criteria General inclusion criteria applying to the five populations are the following:
* Age above 18 years
* BMI between 25 and 40 kg/m²
Inclusion criteria according to study group are listed below.
Group 1: Patients with uncomplicated diabetes and low cardiovascular risk, additional inclusion criteria are:
* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* no history of cardiovascular event, diabetic microvascular complications (kidney function normal and albuminuria/creatininuria \< 30 mg/g)
* Coronary artery calcium score \< 100 (assessment \< 12 months)
Group 2: Patients with uncomplicated diabetes and high cardiovascular risk, additional inclusion criteria are:
* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* no history of cardiovascular eventand diabetic nephropathy no more than stage 2 (i.e. GFR ≥ 60 ml/min by MDRD or CKD-EPI formula and albuminuria/creatininuria ≤ 30 mg/g)
* Coronary artery calcium score \> 400 (assessment \< 12 months)
Group 3: Patients with complicated diabetes, additional inclusion criteria are:
* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* A history of cardiovascular event (myocardial infarction, stroke, peripheral vascular disease, or angioplasty) at least 3 months ago
Exclusion Criteria:
* Solid organ or bone marrow transplant patient
* Pregnant or breastfeeding woman
* Absence of free and informed consent
* Non-affiliation to a social security regimen or CMU (universal health coverage)
* Subject deprived of freedom, subject under a legal protective measure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04353869
Study Brief:
Protocol Section:
NCT04353869