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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT06007404
Eligibility Criteria:
Inclusion Criteria:
* Between 14 and 18 years of age
* Tanner stage 4 or 5 (mature adult stage of puberty)
* Normal weight (BMI ≥ 5th percentile \& \< 85th percentile), overweight (BMI \> 86th percentile) \& \< 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c \> 5.7%)
* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes
Exclusion Criteria:
* Currently pregnant
* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management
* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff
* Allergies or intolerance to milk, soy, or palm oil
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
18 Years
Study:
NCT06007404
Study Brief:
Protocol Section:
NCT06007404