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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT01739868
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥18 years)
* Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \< 1 .26 g/L
* And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and \< 1 .26 g/L ; or blood glucose ≥ 1g/l and \< 1,1 g/L WITH HbA1C ≥ 6,5%
* Signed informed consent
* Subjects affiliated with an appropriate social security system
Exclusion Criteria:
* Fasting glycemia ≥ 1.26 g/l
* Fasting glycemia ≤ 1.10 g/l AND HbA1C \< 6,5%
* Fasting glycemia \< 1 g/l
* Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
* Subjects previously treated with insulin, except gestational diabetes
* Severe coagulation disorders
* Thrombocytopenia \< 100 000/mm 3
* Severe psychiatric disorders
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe hepatic insufficiency
* Alcohol abuse (\> 30g/j)
* Contra-indication in the realization of the local anesthetic
* Subject unable to follow the study during the 5 years of follow-up
* Subject exclusion period in a previous study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01739868
Study Brief:
Protocol Section:
NCT01739868