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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT02368704
Eligibility Criteria:
Inclusion Criteria:
* Specific criteria for diabetic patients:
* Having type 2 diabetes for at least 6 months
* HbA1c ≤ 8%
* Treated by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin
* No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months
Specific criteria for control subjects:
* Nondiabetic subjects (fasting blood glucose \<7.0 mmol / l without hypoglycemic treatment).
* The control subjects should be matched to patients for age (± 5 years), sex, and BMI (± 2 kg/m2).
Common criteria for patients and control subjects:
* Aged 18 to 60 years
* Body Mass Index between 25 and 35 kg/m2
* Accepting the constraints of the protocol and who signed the informed consent
* Systolic blood pressure \< 160 mmHg, diastolic blood pressure \< 90 mm Hg (with or without antihypertensive treatment)
* Resting heart rate between 55 and 100 beats/min.
* Normal laboratory tests or not clinically significant abnormality for NFS platelets, PT, aPTT, fibrinogen ALT, AST, GGT, Serum electrolytes, urea, creatinine, Uric acid Triglycerides, total cholesterol, HDL cholesterol
* HCG negative blood (for female subjects)
* Affiliated to the Social Security.
Exclusion Criteria:
* Current infections or recent infections (\<10 days)
* Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
* Poisoning smoking (\>10 cigarettes per day, what ever the duration of intoxication)
* Treatment with insulin or glitazones Pregnancy, Breastfeeding
* Body Mass Index \> 35 kg/m2
* Any drug taken for less than 8 days without the inclusion of minor analgesics (aspirin, paracetamol), anti-hypertensive medications, oral hypoglycemic (metformin and sulphonylureas) and insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4) and oral contraceptives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02368704
Study Brief:
Protocol Section:
NCT02368704