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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT04893135
Eligibility Criteria:
Inclusion Criteria:
Group G1:
* Male or female patient aged 18 to 70, not practicing regular physical activity (Baecke score \<10)
* Patient with type 2 diabetes for at least 1 year
* Patient treated with metformin +/- SU +/- DPP4 inhibitor +/- GLP1 analogue +/- insulin therapy
* Patient insufficiently balanced under his current treatment with an HbA1c level\> 8.5% for 6 months.
* Patient able to practice physical activity on a regular basis
* Patient having performed a coronary artery disease screening test in the year prior to inclusion
* Woman of childbearing age with effective contraception put in place and monitored throughout the trial
* Patient having given his consent to participate in the study and having signed an informed consent
* Within the G1 group, a controlled 1: 1 randomization, stratified on age (≤65 years or\> 65 years) and BMI (≤ 30 or\> 30) will determine the inclusion of patients in the G1A group (correction of HbA1c) or G1B (correction of HbA1c + physical activity).
Group G2:
* Male or female patient aged 18 to 70, not practicing regular physical activity
* Patient with type 2 diabetes for at least 1 year
* Patient treated with metformin +/- SU +/- DPP4 inhibitor +/- GLP1 analogue +/- insulin therapy
* Patient balanced under his current treatment with an HbA1c level \<7% for 6 months.
* Women of childbearing potential with effective contraception put in place and monitored throughout the trial
* Patient having given his consent to participate in the study and having signed an informed consent
* Matching with the last patient included in group G1 on age (± 5 years), sex, duration of diabetes (± 2 years) and BMI (± 2kg / m2).
Exclusion Criteria:
* Fetal and maternal pathologies requiring maturation Patient with type 1 diabetes
* Patient with regular physical activity
* History of severe cardiovascular pathologies (myocardial infarction, or acute coronary syndrome, or stroke in the past year)
* Patient with a history of severe hypoglycemia in the 6 months preceding entry into the study and / or not experiencing hypoglycemia at all
* Patient pregnant or likely to be
* Severe obesity (BMI\> 35kg / m2)
* Other pathologies likely to interfere with the glycemic variation: in particular the use of corticosteroids during the study
* Patient already having Charcot's neuroarthropathy or symptomatic autonomic neuropathy: orthostatic hypotension and / or gastro-paresis
* Patient with preproliferative diabetic retinopathy
* Patient having anti RANKL treatment
* Subject under tutorship or curatorship
* Subject not affiliated to social security.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04893135
Study Brief:
Protocol Section:
NCT04893135