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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT03416127
Eligibility Criteria:
Inclusion Criteria:
* Patients both sexes
* Age between 30 and 60 years
* Mild to moderate physical activity
* Stable body weight for at least 12 weeks prior to the study
* BMI 25.0 - 34.9 kg/m2
* Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \>126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \>200 mg/dl
* Informed consent signed
Exclusion Criteria:
* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Previous treatment for glucose
* Fasting glucose ≥250 mg/dL
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Hypersensibility to ingredients of intervention
* Known allergies to bee stings or their derived products
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT03416127
Study Brief:
Protocol Section:
NCT03416127