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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01269034
Eligibility Criteria:
Inclusion Criteria:
1. Age between 12-18 years of age at the time of enrollment.
2. Diagnosed with antibody positive T1DM in the past 3 months.
3. Otherwise healthy except for their TIDM and treated hypothyroidism.
4. Females must have a negative pregnancy test.
5. Hemoglobin equal to or greater than 12 g/dl before each study.
6. Weight greater than 44 kg.
Exclusion Criteria:
1. Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
2. Any medications that may affect glucose metabolism.
3. Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
4. Lack of a supportive family environment as detected by the clinicians and/or social workers.
5. History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
6. Positive pregnancy test in females.
7. Lactating and nursing mothers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT01269034
Study Brief:
Protocol Section:
NCT01269034