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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05477134
Eligibility Criteria:
Inclusion Criteria:
1. Youth with type 2 diabetes and healthy controls who meet other inclusion criteria outlined below.
2. Age and pubertal stage criteria (12- to 20-year-old girls who are postmenarchal, and 14- to 20-year-old boys who are at Tanner stage 5 genitalia),
3. Additional criteria for youth with diabetes: i. diagnosis of T2D, and ii. diabetes duration between 3 months and 10 years.
Exclusion Criteria:
1. Previous history of diabetic ketoacidosis (DKA)
2. Poorly controlled diabetes defined as HbA1c \>7.5%,
3. Abnormal liver, thyroid, gonadal or adrenal functions,
4. Renal insufficiency defined by eGFR (estimated glomerular filtration rate) \<90 mL/min/1.73 m2,
5. Any glucose lowering medications except metformin, insulin and liraglutide
(7) Any medication use that will likely to interfere amino acid metabolism, (8) Any hormonal replacement therapy, and (9) Pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
20 Years
Study:
NCT05477134
Study Brief:
Protocol Section:
NCT05477134