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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03606694
Eligibility Criteria:
Inclusion Criteria:
* Patients both sexes
* Age between 30 and 60 years
* Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \>126 mg/dL; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \>200 mg/dl; or glycosylated hemoglobin between \>6.5%)
* Informed consent signed
Exclusion Criteria:
* Women with confirmed or suspected pregnancy, or under lactation and/or puerperium
* Previous treatment for glucose
* Fasting glucose ≥250 mg/dL
* Body Mass Index ≥34.9 kg/m2
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Hypersensibility to ingredients of intervention
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
* Blood Pressure ≥140/90 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT03606694
Study Brief:
Protocol Section:
NCT03606694