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:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT06895018
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) \>25 and ≤35 kg/m2
* Cholesterolemia ≤ 250 mg/dl and Triglyceridemia ≤ 200 mg/dl.
* type 2 Diabetes in good glycemic control (Hb1Ac ≤7.5%) treated with diet alone or diet + metformin.
Exclusion Criteria:
* Cardiovascular events (myocardial infarction and/or stroke)
* Renal insufficiency (serum creatinine \>1.5 mg/dl) and liver failure (ALT/AST twice the normal values)
* Anemia (Hb \<12 g/dl) or other chronic disease
* Insulin therapy and other hypoglycemic drugs other than metformin
* Habitual intense physical activity
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT06895018
Study Brief:
Protocol Section:
NCT06895018